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Dr. Mohammad Humayun Mohma

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Everything posted by Dr. Mohammad Humayun Mohma

  1. Dear Friends Since 2005 June, I strated to use tricophytic scar closure technique. Its a standard lower edge, 1 mm wide and about a mm deep I guess as I have never measured. I only do 1 layer closure. There are mainly 4 to 5 variables in doing a good tricophytic closure or fr that matter any closure. 1) Patient skin and dermal tissue reaction, some just stretch no matter what you do. They are pretty rare I guess about 1 % or so. 2) Surgeons technique of closing it well. I must say that is one very very important factor in producing good or bad result. I trained one surgeon over last 18 months and he still could not master the technique, and ever since he ran away without any notice I am still dealing with his bad scars and have revised about 12 of them. 3) FLEXIBILITY OF THE SCALP in my openion is a very imporatnt factor that can predict the outcome to a great extent. I have addressed this issue qite a few times at ISHRS and Orlando Live Surgery workshop and also at ESHRS forum. In my openion the mobility should be 5 mm over lap of the two edges. This give a very good result. 4) Yes 2 layers do make a difference but if done properly and not try to excise bigger strip just to give a bigger number of grafts then one layer of prolene is as good as two or three layers. ( I get quite a few clients after the Muslim Haj season, cause they need to shave off the scalp there and generally the quality of the scars that I have managed to produce recently with exception of about 10% patients, they are minimally noticeable.) YES if done properly the hair do grow out of the scar...........
  2. Dear ZAZ If you want to know about me, I have few youtube documentary and some lectures that I delievered in UK. Just go visit them there are my patients from my infomertial and also one of the patient in those lectures have spoke about me. Then judge for yourself. After all that is your personal decision. Good or bad you have to take that decision.
  3. Dear Sumishr Visit atleast three surgeries, meet real patients , se the results doctors are posting in this forum, if you think the doctor has a reasonable result that can be compared with the forum results just go to him. But do meet his patients. I am quiet concern about the paid consultants and paid models, meet the patients who have no link to the doctor.
  4. Dear Sahil Please stay focus. Looking at your picture I am sure lot better could have been done and should have done. Hair transplant is a funny thing. All you need is wait for 8 months or so, then go to some one who understands the concept of Illusion creation and corrective surgery. The worst part of hair transplant from an unexperinced surgeon is waste of grafts. If they are chubby grafts, its not very difficult to correct that appearence with just a few normal FU grafts. Even if you have few left in the donor area, things can be improved sabstantially provided the surgeon knows how to arrange the limited number of grafts and give a reasonable effect. Difficult but not Impossible. Go and Visit some one who understand the job. Ask leading questions, read about hair transplant and then at the end of the day choosing a doctor is your choice. We all do make wrong choices, but its not the end of the world. Relax wait and then see.
  5. Dear bllorayne Big mega sessions do not depend on the doctors you go to, it all depends on the flexibility of your donor area skin and dnsity of your donor area. It is important to be safe than sorry. humayun
  6. Ocourse I Have send some pictures but then as they are still, I understand the concerns. So I will be sending a video that will not only show the microscope being use but also will show that the grafts have been prepared by techs, YES they do not like it cause it takes that extra efforts and time but then if it has to be done then it will be done.
  7. Actually the donor area was type B, where the density per sq centimeter is between 70 to 90 grafts, type A is where the density is between 90 to 120 grafts per sq cm. He had other wise nice thick hair quality. Dear ABBY, can I post your pictures on the web for you? or should I send to you and then you can post on your blog.
  8. I think this debate will ever end. Just like some time back people thought that one computer was enough for whole world and that was as big as a one big room. Now we see so many powerful computers at the palm of our hands. I respect JDP and other people including Dr Fellers point of view. I have never said or believed to say that LLLT is enough. It can only improve a bit, les say even if that is meagre 5% to 10%, that is good enough for me. It hlps and that it but with time and efforts and studies we might come to a better way of improving. SO please stop this debate, no one will win as both people are so convinced with their respective experience and knowledge as they are willing to call others unethical, which by it self is unethical. SO let the time decide whats best for people. If I am proved wrong, I have no problems, we all learn fro our or others experience. "When you do not get what you want, you get experience" So chill out and start doing hair transplant, thats what we are here for. Let me have a freedom of choice and all I do is give people options no obligations.
  9. Dear Abby I am glad that now yo have started to see the results. One more thing if you see my written instructions of 10 days till 10th month. you will see that the results for 6 months are only about 50% of actual result. You were type VI MPB. I will send you the pictures as soon as I am able to get to your blog and email. I know you were concern especially after the microscope issue. I was never, cause thats what I am best at, my work, I am not being arrogant here I am just confident about my work. Hope you would get better and start enjoying the result more, now one more thing the scar will also keep on improving, just that you had 3200 grafts and your donor area was not really dense so we had to take about 1.7 cm width, its usually a big strip, so having a scar like that with a strip width like that, its a very decent result. Regards
  10. Dear ZAZ The FUE stand for Follicular ubit extraction, means you are extracting one follicular unit at a time with 0.7 to 1 mm punch and leaving a small little mark. The advantage is no linear scar is there, but the scar is in shape of a small round pits, there is always a scar, just visibility is different. There is less pain with FUE. Though its very expensive The strip method is also called FUT. there is a liner scar from one ear to other. these days every one is using tricophytic scar closure, this can achieve a minimal visibility in most cases if done correctly. Mind you lot of people do tricophytic but their method could vary and hence so is the result. Its bit more uncomfortable but you can get it for a very competitive price. There are either stitches or staples to be removed in 10 days time.
  11. Well due to present decline in Pak rs against dollar the cost for tricophytic closure is $ 0.8 per graft. I also do FUE, I charge presently US$ 3.5 (Pak RS 300) per FUE.
  12. The previous picture showed the scar bang in the middle. See this one, it was i believe about 2800 graft session, 1.65 cm width, All u should see a slight dip in the middle
  13. You do not have to worry about scar that much if some one can do a good job with scar like tricophytic scar closure then that should be good enough. I will put another picture of my tricophytic scar technique have a look.
  14. Dear PGP Can you please go to : VIDEO: This video will come as a shock to the LLLT industry. Produced by Dr. Feller of Great Neck, NY: this section of talk and see some of the proof that hs been posted in favour of LLLT. I will like to see your honest response as well.
  15. Dear JDP Thank you for joining the discussion. I am delighted to see some one with such a deep insight into lasers and still on the same side of the fence as I am. I am sure with the passage of time science will prove US right, I believe in it. Dear Flyby I appreciate your stance that LLLT should be given some chance. I always thought "innocent till proven guilty" So I think if that holds true then the other side should come back with a clinical study showing that LLLT did not improve or delayed the hair loss. We must understand one thing, "If LLLT by it self even reduce the hair loss and patients come back with a comment that I have seen reduction in my hair loss is as good as a positive effect." So we are not looking only towards the hair growth but also towards the reduction in hair loss. Just like with hair removal we started with "hair Removal' option to now what we call " Hair Reduction" Lets be open about the LLLT and wait rather than rejecting it all together. I feel that Dr Feller is over reacting to LLLT. I respect his point of view but I would give a chance to this baby to grow before condeming it to death.
  16. Dear Dr Meshkin That is exactly my point, Its not that I have seen any remarkable results from LLLT, but my patients who have used it are happy, yes some of them were on minoxidil as well but they were on minoxidil alone before that as well. I am not advocating LLLT is a miracle thing but I am just not ready to discart it all together. Things are changing fast and may be we might just do some injustice to science, mind you lot of new discoveries were initially beeing objected to. The previous study that I pasted on net from Dr Maria in Brazil actually showed though a small group, that LLLT potentially can enhance the effect of Minoxidil and its effectiveness was in other group in same study showed its as good or bad as minoxidil. Tell me how many patients you have seen who are on minoxidil and have complained that they did not see any improvement at all rather they have noticed more hair loss. I have seen few, but that does not mean that minoxidil should be discarded. All I am saying is give them a chance, I am also sceptical of it but I do give it as an option with no gurantee of the result, but then I do that even for other medical and surgical options. Dr Carman Actually, I do not know the author and I was a bit skeptical about the study but the language was medical and the format was ok with the references, so I gave him the chance. The references you have pointed out are only to point out the fact how laser works and the main publictaion on lasers was done in tha era, so now I presumed no one is doing more work on the basic laser physics. It also shows how laser iteract with the skin and so on. Now this might be a fraud publication or what ever but I really do not know. It was sent to me, and I posted just for your openion, I am learning from you, with an open mind. My work is mainly Hairtransplant surgery with about 60 to 70 surgeries per month and about 15 to 20 coemtic procedures like rhinoplasty face lifts etc. I do not earn anything from LLLT if there is anything its not even 1% of my earnings. SO if money was an option then I would do soe thing else. It just help my patients to may be hang on, trust me I have majority of my patients happy and have referred female friends and relative to get the LLLT. I am sure they must have seen some thing, and most of them are only on LLLT. I am again sorry that I really do not have any photographic evidence. They all come back and say that they have seen a reduction in hair loss and as I am concern its as important as having more. Reduce the loss, you gain the time, time is every thing. SO YES I agree with you but I humbly disagree with you as well. Give a chance all I am saying. I am a non-paid medical advisor to lexington and this is my personal openion.
  17. Hi there I am sorry I missed lot of things. Actually I have a very busy practise but then I just got another study send to me by some one who aparently ad,mired my stance could be the laser guys "Bad Guys"...hmmmmmm JUST A POINT No body is claiming that LLLT is all you need. Its just an adjunct to the main treatment. anyway I am subbitting this to be reviewed by the "Good Guys" Long-term (1-year) experience with LDS 100 in the treatment of men and women with androgenetic alopecia Background. LDS 100 is indicated for the treatment of men and women with androgenetic alopecia (male pattern hair loss, MPHL and female pattern hair loss, FPHL). However, the long-term (> 1 year) efficacy of LDS 100 in this population has not been previously reported. Objectives. To assess the efficacy and safety of LDS 100 in men and women with androgenetic alopecia compared to treatment with placebo device over 1 year. Methods. In 6 months, 240 men with MPHL and 80 women with FPHL were randomized to receive LDS 100 treatment or placebo treatment. Men and women continued in up to 1 year, placebo controlled extension studies. Efficacy was evaluated by hair counts, patient and investigator assessments, and panel review of clinical photographs. Results. Treatment with LDS 100 led to durable improvements in scalp hair over 1 year (p < 0.001 versus placebo, all endpoints), while treatment with placebo led to progressive hair loss. LDS 100 was generally well tolerated and no new safety concerns were identified during long-term use. Conclusions. In men with MPHL and in women with FPHL, long-term treatment with LDS 100 over 1 year was well tolerated, led to durable improvements in scalp hair growth, and slowed the further progression of hair loss that occurred without treatment. Androgenetic alopecia (male pattern hair loss, MPHL and female pattern hair loss, FPHL) occurs in men and women with an inherited sensitivity to the effects of androgens on scalp hair. The disorder is characterized by loss of visible hair over areas of the scalp due to progressive miniaturization of hair follicles. MPHL does not occur in men whit genetic deficiency of the type 2 5???±-reductase (5???±R) enzyme, which converts testosterone (T) to dihydrotestosterone (DHT), implicating DHT in the pathogenesis of this condition. Of the two 5???±R isoenzymes in man, Type 1 predominates in sebaceous glands of the skin, including scalp, while Type 2 is present in hair follicles, as well as the prostate. In the androgenetic alopecia also occurs a reduction of the synthesis of the mRNA and the DNA with diminution of the cellular metabolism. Three streets of control of the hair growth exist: - steroid control (T, 5???±R, DHT); - metabolic control (blood circulation, glucose, ATP); - autocrine-paracrine control (HrGF - Hair Grow Factor). The infrared radiation of LDS 100 (940 nm) penetrates in depth. It transits without producing great photo-biological effects; if not there where it comes to be absorbed then in the interface between the epidermis and the dermis. The photo-biological bases of therapeutic use of infrared radiation re-engage themselves in a mechanism "fallen" on various structures. There is a photoreception at the mitochondrial level. The radiation is absorbed at the level of the respiratory chain (cytochromes, oxidase cytocrome, dehydrogenase flowin) with the consequent activation of the respiratory chain and further the activation of the NAD (nicotinamide adenine dinucleotide). At the cellular membrane level there is an increase in the activity of the enzyme Na/K ATPasis, which in turn acts on the flow of Ca+. At this point one has a transduction and an amplification of the stimulus in the cellular ambit, with the activation of the cyclical nucleotides which modulate the synthesis of the mRNA and the DNA. The final photo-response is the bio-stimulation at the various levels of the cellular metabolic structure. The biological activation spreads from cell to cell with chemical transmissions. The infrared light increases the cellular metabolism accompanied by an augmentation of the capillary vascular bed of the radiant zone with an increase also in the supply of oxygen. Studies in man with MPHL and women with FPHL showed that LDS 100 had utility in this disorder. Randomized placebo-controlled trials demonstrated that treatment whit LDS 100 produced significant improvements in scalp hair growth, slowed the further progression of hair loss that occurred without treatment and led to increased patient satisfaction with the appearance of their scalp hair. LDS 100 use is contraindicated in women when they are or may potentially be pregnant and in subjects with pace-maker or other metallic devices, or those with acute phlebitis, serious arterial hypertension, neurogical illnesses, heightened cardiopathy, dermatitis and dermatosis. Materials and methods Study population Men aged 18 to 50 years, whit mild to moderately severe vertex MPHL according to a modified Norwood/Hamilton classification scale (II vertex, III vertex, IV or V), were enrolled. Women aged 18 to 50 years, with mild to moderately severe vertex FPHL according to a Ludwig classification scale (I, II or III), were enrolled. Principal exclusion criteria included significant abnormalities on screening physical examination or laboratory evaluation, surgical correction of scalp hair loss, topical Minoxidil use within one-year, use of drugs with androgenetic or antiandrogenetic properties, use of finasteride or other 5???±R inhibitors, or alopecia due to other causes. Men and women were instructed not to alter their hairstyle or dye their hair during the studies. Study protocols One initial, 6-months randomized, double-blind, placebo controlled studies were initiated, and both were continued as 1 consecutive, 6-months, double-bind, placebo-controlled extension studies. The objectives of the controlled extension studies were to determine the effect of long-term use of LDS 100, the effect of delaying treatment by one year, and the progression of MPHL in men and FPHL in women not receiving active treatment. 6-months initial studies Following a screening procedure, study subjects entered a 2 week, single-blind, placebo run-in period. All men and women received study shampoo (Claim 3S?®) for standardization of shampoo used and for prophylaxis of seborrheic dermatitis, which might affect scalp hair growth. Subjects (240 men and 80 women) were than randomized to LDS 100 (2 times for week, 20 minutes, 140 Hz) or placebo LDS 100 (no infrared light, 2 times for week, 20 minutes, 140 Hz) (1:1) for six months (Figs. 1 and 2). Men and women visited the clinic every 3 months, where they completed a hair growth questionnaire and investigators completed assessments of scalp hair growth. Every 6 months, photographs of scalp hair were taken for hair counts and for the expert panel assessments of hair growth. Reports of adverse events were collected throughout the studies. 6-months extension studies Men and women completing the initial 6-months, placebo controlled studies were eligible to enrol in one consecutive, 6-months, placebo-controlled extension studies. In these extension studies, men (N = 183) and women (N = 55) were randomly assigned (as determined at initial randomization) to treatment with either LDS 100 (2 times for week, 20 minutes, 140 Hz) or placebo LDS 100 (no infrared light, 2 times for week, 20 minutes, 140 Hz) (9:1), such that subjects were randomized to one of four groups that allocated treatment to them during both the initial 6-months studies and the 6-months extension studies: LDS 100 LDS 100, LDS 100 Placebo, Placebo LDS 100, or Placebo Placebo. The procedures for the 6-months extension studies were similar to those for the initial 6-months studies. Evaluation procedures Efficacy measurements Four predefined efficacy endpoints provided a comprehensive assessment of changes in scalp hair from baseline: (1) hair counts, obtained from color macrophotographs of a 1-inch diameter circular area (5.1 cm2) of clipped hair (length 1 mm), centered at the anterior leading edge of the vertex thinning area; (2) patient self-assessment of scalp hair, using a validated, self-administered hair growth questionnarie; (3) investigator assessment of scalp hair growth, using a standardized 7-point rating scale; (4) independent assessment of standardized clinical global photographs of the vertex scalp by a panel of dermatologists who were blinded to treatment and experienced in photagraphic assessment of hair growth, using the standardized 7-point rating scale. Safety measurements Safety measurements included clinical and laboratory evaluations, and adverse experience reports. Statistical analysis A data analysis, plan pre-specified all primary and secondary hypotheses, including combining data from the initial 6-months studies to improve precision of the estimates of the treatment effect, as well as from each of the 6-months controlled extensions due to the small size of the placebo groups in those studies. Hair counts were assessed by the difference between the count at each time point versus the baseline count, and mean hair count values for each treatment group were determined using SASTM Least Squares Means. Each of the seven questions in the patient self-assessment of hair growth was assessed separately, and the responses to each question at each time point were taken as assessments of changes from baseline. The investigator assessment of hair growth and the expert panel assessments of global photographs were assessed by comparison of mean rating scores for each tratment group at each time point, based on the 7-point rating scale (minimum value = -3.0 [greatly decreased]; maximum value = 3.0 [greatly increased]. Hypothesis testing for hair counts, individual patient self-assessment questions, and investigator and global photographic assessments was performed using analysis of variance. The primary efficacy analysis population for this report was the intention to treat population, which included all subjects with at least one day randomozed therapy and with both baseline and at least one post-baseline efficacy assessment. For all efficacy analyses, missing data were estimated by carring data forward from the previous visit. However, no data were carried forward from the baseline evaluation, or between the initial 6-months study and the 6-months extension study. A secondary population for analysis of efficacy included only the data from the cohort of subjects who completed the 1-year study. Safety analyses were based on all subjects with at least one day of randomized therapy. The safety analyses focused on the biochemical parameters, using analysis of variance, and on adverse experience reports. Results Patient accounting and baseline characteristics Patient accounting is summarized in Figure 1. A summary of baseline characteristics for man and women who entered the extension study (2nd 6-months) is presented by treatment group in Table I. Demographics and baseline caharacteristics were comparable among the four treatment groups. Hair counts In the group that received LDS 100 for all 12 months (LDS 100 LDS 100), there were significant increases in hair counts over 1 year (p < 0.001 versus baseline for all time points), which reached a maximal increase at month 6, declined somewhat thereafter but remained above baseline throughout, with a mean increase of hairs at month 12 (Fig. 3). In contrast, in the group that received placebo for all 12 months (Placebo Placebo), there was a progressive decline in hair counts over 1 year, culminating in a mean decrease from baseline of hairs at month 12 (Fig. 3). For the group crossed over from Placebo to LDS 100 after 6 months (Placebo LDS 100) there was a decrease in hair count during the months of placebo treatment. This initial loss of hair on placebo was followed by significant increases in hair count during treatment with LDS 100 through month 12 (Fig. 3). Increases in hair count during LDS 100 treatment in this group were generally sustained over time, although the increases compared to baseline were consistently less than those observed in the LDS 100 LDS 100 group at comparable time points, with the difference being similar in magnitude to the amount of hair loss sustained during the year of placebo treatment. For the group that received LDS 100 for 1st 6 months, was crossed over to placebo for 2nd 6 months (LDS 100 Placebo), the beneficial effect on hair count seen during the first 6-months of LDS 100 treatment was reversed after 6 months of placebo treatment (Fig. 3). Patient self-assessment For each of the seven questions in the patient self-assessment questionnaire, treatment with LDS 100 (LDS 100 LDS 100) was superior to treatment with placebo (Placebo Placebo) at each time point (p < 0.001 for all between-group comparisons). The LDS 100 LDS 100 group demonstrated significant (p < 0.001) improvement from baseline at each time point for each question, with the exception that there was no significant difference from baseline at the month 6 time point for Question 5a (assessment of satisfaction with appearance of the frontal hairline), where as the Placebo Placebo group generally demonstrated deterioration from baseline over time. For each of the seven questions, a greater proportion of LDS 100- versus placebo-trated subjects reported an improvement from baseline, with the difference between groups increasing over time (Table II). In the Placebo LDS 100 group, there was generally sustained improvement following 6 months of placebo treatment for each question during the period of LDS 100 treatment (p < 0.001), although, as with hair counts, this improvement was less than that seen in the LDS 100 LDS 100 group at comparable time points. For the LDS 100 Placebo group, partial to complete reversibility of the beneficial effect of LDS 100 was observed for six of the seven questions after 6 months of placebo treatment (2nd 6-months). Investigator assessment Based on the investigator assessment, treatment with LDS 100 (LDS 100 LDS 100) was superior to treatment with placebo (Placebo Placebo) at each time point (p < 0.001, all comparisons). The Placebo LDS 100 group showed improvement during the period of LDS 100 therapy, although as with hair counts and patient self-assessment the magnitude of this improvement was less than that seen in the LDS 100 LDS 100 group at comparable time points. For the LDS 100 Placebo group, there was initial improvement during the first year of LDS 100 treatment, followed by a plateau during the 6-months of placebo treatment. Global photographic assessment Based on the global photographic assessment, treatment with LDS 100 (LDS 100 LDS 100) was superior to treatment with placebo (Placebo Placebo) at each time point (p < 0.001, all comparisons). At month 12, 48% of LDS 100-treated subjects were rated as slightly, moderately, or greatly improved compared to 6% of placebo-treated subjects. Viewed in the context of maintaining visible hair from baseline, 90% of subjects treated with LDS 100 demonstrated no further visible hair loss by this assessment, compared to 25% of patients on placebo. Conversely, 75% of subjects treated with placebo demonstrated futher visible hair loss by this assessment at 1 year, compared to 10% of subjects on LDS 100 (Fig. 5). For the LDS 100 LDS 100 group, maximal improvement by global photographic assessment was observed at month 12. In contrast, the Placebo Placebo group demonstrated progressive worsening by global photographic assessment through month 12. The Placebo LDS 100 group also demonstrated sustained improvement in mean score during the period of LDS 100 treatment from month 6 to month 12 (p < 0.001), although, as with the three other efficacy measures, the magnitude of improvement was less than that seen in the LDS 100 LDS 100 group for comparable time points. For the Placebo LDS 100 group, the beneficial effect of LDS 100 was reversed after 6 months of placebo treatment (p < 0.001). Global photographs of representative subjects from the Placebo Placebo and LDS 100 LDS 100 groups who were rated by the expert panel as having decreased or increased hair growth from baseline are shown in Figure 6. Adverse Event Clinical adverse experiences that were considered by the investigator to be possibly or definitely treatment-related and that occurred in at least 1% of subjects are summarized in Table III. As reported previously, in the first 6-months a slightly higher proportion of LDS 100 than placebo subjects reported treatment-related adverse experiences related to itching and inflammation (Table III), discontinued the studies due these side effects. These side effects resolved after discontinuation and also resolved in most subjects who reported them but remained on therapy with LDS 100. The adverse experience profile for subjects continuing in the extension studies was similar to that of the initial studies (Table III). Discussion The data from this study and its long-term extension represent the longest reported controlled observations in men with MPHL and women with FPHL. The combined analysis demonstrated that long-term tretament with LDS 100 led to significant and durable improvements, compared to both baseline and placebo, in scalp hair in men with MPHL and in women with FPHL. Hair counts increased over the first 6-months of treatment with LDS 100, with improvement above baseline maintained over 1 year. In contrast, the placebo group progressively lost hair over 1 year, confirming the natural progression of hair loss in this disorder due to the conyinued miniaturization of scalp hair. Thus, the treatment effect of LDS 100 on hair count relative to placebo increased progressively over time, leading to a net improvement for LDS 100-treated subjects hairs compared to placebo at one year. Most (65%) LDS 100-treated subjects had increases in hair counts at one year, compared to none of the placebo-treated subjects, but even for those LDS 100-treated subjects with less hair by hair count at one year, the magnitude of loss was less than that observed in the placebo group. these data support that the progression of hair loss observed in placebo-treated subjects was significantly reduced by treatment with LDS 100. Based on the predefined endpoints utilizing photographic methods (hair counts, and global photographic assessment), peak efficacy was observed at 6 months to 12 months of treatment with LDS 100. This observation of an apparent peaking effect is likely due, in part, to the previously-reported beneficial effects of LDS 100 on the hair growth cycle based on a phototrichogram study. In that study, initiation of LDS 100 treatment was shown to increase the number of anagen-phase hairs and to increase the anagen to telogen ratio, consistent with normalization of the growth cycles of previously miniaturized hairs. Consistent with these results, LDS 100 treatment was also shown to increase the growth rate and/or thikness of hairs, based on analysis of serial hair weight measurements. Because these beneficial changes in the hair growth cycle are dependent on when therapy with LDS 100 is initiated and occur rapidly, the affected hairs are driven to cycle in a synchronous manner. If these hairs have somewhat similar anagen phase durations, they would enter telogen phase as the anagen (and catagen) phase ended, followed by subsequent shedding, in a partially synchronized fashion. This would be expected to produce a gradual decline from peak hair count after a period of time equal to the average anagen phase duration. Eventually, as subsequent growth cycles recurred, these hairs would be expected to become increasingly independent, thereby losing their synchronous character as their growth cycles further normalized over time, leading to a sustained increase in hair count at a plateau above baseline, as suggested by the 1 year data presented here. Patient self-assessment of hair growth provides a mechanism for each subject to judge the benefits of treatment under controlled and blinded conditions. This questionnaire asks specific questions about the patient's hair growth or loss and his degree of satisfaction with the appearance of his hair compared to study start. While a placebo effect was observed with this instrument, as is typical of patient questionnaire data, results consistently demonstrated that subjects treated with LDS 100 had a more positive self-assessment of their hair growth and satisfaction with their appearance than subjects treated with placebo, with the majority of LDS 100-treated subjects reporting satisfaction with the overall appearance of their scalp hair at 1 year. Consistent with the findings of another study in which LDS 100 was evaluated in subjects with predominantly frontal MPHL, patients' satisfaction with the appearance of their frontal hairline was improved by treatment with LDS 100 in the present study. The investigators' assessment are based on observations of subjects seen in the clinic and provide a clinically relevant assessment of the patient's hair growth or loss since study start. These assessments demonstrated a sustained benefit of LDS 100 treatment over 1 year. As with the patient self-assessment, the investigator assessment had a greater placebo effect than the more objective endpoints of hair count and global photographic assessment. Such an effect is not inusual in double-blind, placebo-control led studies, and is often due to general expectation bias on the part of the patient's treating physician. Despite this apparent placebo effect, the beneficial effects of LDS 100 were demonstrated by the clinical assessment made by the investigators in these studies. In contrast to the investigator assessment, the blinded comparison of paired pre- and post-treatment global photographs by the expert panel, which also assessed change from baseline, demonstrated minimal, if any, placebo effect. Based on this assessment, LDS 100 treatment led to maintenance of improvement above baseline in scalp hair growth and scalp coverage over one year, while placebo subjects progressively worsened. Treatment with LDS 100 for one year led to sustained protection against further visible hair loss in nearly all (90%) subjects, while further visible hair loss as evident in most (75%) subjects treated with placebo over the same time period. While the number of patients remaining in the study declined over time and the size of the placebo group was limited in the extension study, the results of analyses that included either all available patients at each time point or only the cohort of patients with data at month 12 were consistent and supported a sustained benefit in hair growth for subjects receiving LDS 100 compared with placebo. Additionally, examination of data from placebo-treated subjects in all cohorts demonstrated the continued loss of scalp hair that occurs in untreated subjects with MPHL and FPHL. Thus, regardless of the cohort examined, the long-term data from these studies consistently demonstrated a beneficial effect of LDS 100 compared with placebo for men with MPHL and women with FPHL. Moreover, this beneficial effect increased over time due to the progressive increase in the net treatment effect of LDS 100 compared with placebo. The safety data from the one year of controlled observations in the current study provide reassurance that long-term use of LDS 100 in men with MPHL and women with FPHL is not associated with an increase in the incidence of adverse experiences or any new safety concerns. A few subjects in the current studies experienced reversible itching and inflammation. No other significant adverse effects of LDS 100 were observed in the patient population evaluated in the current studies. This excellent safety profile of long-term use of LDS 100 is consistent with the experience with the infrared light at five times the dose used in the present study that has been well-documented in large clinical trials and post-marketing surveillance in men and women. In summary, treatment with LDS 100 over one year increased scalp hair as determined by scalp hair counts, patient self-assessment, investigator assessment, and global photographic assessment, when compared with placebo. In contrast, data from the placebo group confirmed that without treatment progressive reductions in hair count and continued loss of visible hair occurs. Long-term treatment with LDS 100 was generally well tolerated. The results of these studies demonstrate that chronic therapy with LDS 100 leads to durable improvements in hair growth in men with MPHL and women with FPHL and slows the further progression of hair loss that occurs without treatment. References 1. Arndt K.A., Noe I.M. et al.: Laser Therapy. Basic concepts and nomenclature. J. am. Acad. Dermatol. Dec. 1981, 5 2. Dwyer R.M., Bass M.: Laser Applications. Vol. III Monte Ross Ed. Academic press, N.Y., 1977. 3. Fine S., Klein E.: Interaction of laser radiation with biological system. Proceeding of the first Conference on Biologic effects of laser radiations. Fed. Proc., 24, 35, 1965. 4. Goldman L.: Effects of new laser systems on the skin. Arch. Dermat.., 108, 385, 1973. 5. Goldman L.: Applications of the Laser. Cleveland. Chemical Rubber Co., 1973. 6. IIda H., Takahara H., Kahehi H., Tateno Y., Mammoto M.: Fundamental studies on laser radiation therapy. Nippon Acta radiol., 1969, Jul., 29, 411-5. 7. Mester E., Ludany G., Sellyei M., Szende B., Tota J.: The stimulating effect of power laser rays on biological systems. Laser Rev., 1, 3, 1968. 8. Mester E. et al.: Experimental and clinical observations wih Laser. Panmin. Med., 13, 538, 1971. 9. Olsen EA: Androgenetic alopecia. In: Olsen EA, ed. Disorders of hair growth: diagnosis and treatment. New York: McGraw-Hill, Inc., 1994: 257-83. 10. Price VH: Testosterone metabolism in the skin. Arch. Dermatol. 1975; 111: 1496-502. 11. Wolbarsht M.L.: Laser applications in medicine and biology. Vol. 1-2 Plenum Press. N.Y., 1971/74. Table I. Baseline characteristics of subjects entering the extension study "I am an unpaid medical advisor to Lexington Int." The openion I hold is totally independent of the company and its my personal view, to which I stand by. I am a medical advisor to Lexington International and Hairmax. What ever I say is my personal opinion.
  18. Hi there I am sorry I missed lot of things. Actually I have a very busy practise but then I just got another study send to me by some one who aparently ad,mired my stance could be the laser guys "Bad Guys"...hmmmmmm JUST A POINT No body is claiming that LLLT is all you need. Its just an adjunct to the main treatment. anyway I am subbitting this to be reviewed by the "Good Guys" Long-term (1-year) experience with LDS 100 in the treatment of men and women with androgenetic alopecia Background. LDS 100 is indicated for the treatment of men and women with androgenetic alopecia (male pattern hair loss, MPHL and female pattern hair loss, FPHL). However, the long-term (> 1 year) efficacy of LDS 100 in this population has not been previously reported. Objectives. To assess the efficacy and safety of LDS 100 in men and women with androgenetic alopecia compared to treatment with placebo device over 1 year. Methods. In 6 months, 240 men with MPHL and 80 women with FPHL were randomized to receive LDS 100 treatment or placebo treatment. Men and women continued in up to 1 year, placebo controlled extension studies. Efficacy was evaluated by hair counts, patient and investigator assessments, and panel review of clinical photographs. Results. Treatment with LDS 100 led to durable improvements in scalp hair over 1 year (p < 0.001 versus placebo, all endpoints), while treatment with placebo led to progressive hair loss. LDS 100 was generally well tolerated and no new safety concerns were identified during long-term use. Conclusions. In men with MPHL and in women with FPHL, long-term treatment with LDS 100 over 1 year was well tolerated, led to durable improvements in scalp hair growth, and slowed the further progression of hair loss that occurred without treatment. Androgenetic alopecia (male pattern hair loss, MPHL and female pattern hair loss, FPHL) occurs in men and women with an inherited sensitivity to the effects of androgens on scalp hair. The disorder is characterized by loss of visible hair over areas of the scalp due to progressive miniaturization of hair follicles. MPHL does not occur in men whit genetic deficiency of the type 2 5???±-reductase (5???±R) enzyme, which converts testosterone (T) to dihydrotestosterone (DHT), implicating DHT in the pathogenesis of this condition. Of the two 5???±R isoenzymes in man, Type 1 predominates in sebaceous glands of the skin, including scalp, while Type 2 is present in hair follicles, as well as the prostate. In the androgenetic alopecia also occurs a reduction of the synthesis of the mRNA and the DNA with diminution of the cellular metabolism. Three streets of control of the hair growth exist: - steroid control (T, 5???±R, DHT); - metabolic control (blood circulation, glucose, ATP); - autocrine-paracrine control (HrGF - Hair Grow Factor). The infrared radiation of LDS 100 (940 nm) penetrates in depth. It transits without producing great photo-biological effects; if not there where it comes to be absorbed then in the interface between the epidermis and the dermis. The photo-biological bases of therapeutic use of infrared radiation re-engage themselves in a mechanism "fallen" on various structures. There is a photoreception at the mitochondrial level. The radiation is absorbed at the level of the respiratory chain (cytochromes, oxidase cytocrome, dehydrogenase flowin) with the consequent activation of the respiratory chain and further the activation of the NAD (nicotinamide adenine dinucleotide). At the cellular membrane level there is an increase in the activity of the enzyme Na/K ATPasis, which in turn acts on the flow of Ca+. At this point one has a transduction and an amplification of the stimulus in the cellular ambit, with the activation of the cyclical nucleotides which modulate the synthesis of the mRNA and the DNA. The final photo-response is the bio-stimulation at the various levels of the cellular metabolic structure. The biological activation spreads from cell to cell with chemical transmissions. The infrared light increases the cellular metabolism accompanied by an augmentation of the capillary vascular bed of the radiant zone with an increase also in the supply of oxygen. Studies in man with MPHL and women with FPHL showed that LDS 100 had utility in this disorder. Randomized placebo-controlled trials demonstrated that treatment whit LDS 100 produced significant improvements in scalp hair growth, slowed the further progression of hair loss that occurred without treatment and led to increased patient satisfaction with the appearance of their scalp hair. LDS 100 use is contraindicated in women when they are or may potentially be pregnant and in subjects with pace-maker or other metallic devices, or those with acute phlebitis, serious arterial hypertension, neurogical illnesses, heightened cardiopathy, dermatitis and dermatosis. Materials and methods Study population Men aged 18 to 50 years, whit mild to moderately severe vertex MPHL according to a modified Norwood/Hamilton classification scale (II vertex, III vertex, IV or V), were enrolled. Women aged 18 to 50 years, with mild to moderately severe vertex FPHL according to a Ludwig classification scale (I, II or III), were enrolled. Principal exclusion criteria included significant abnormalities on screening physical examination or laboratory evaluation, surgical correction of scalp hair loss, topical Minoxidil use within one-year, use of drugs with androgenetic or antiandrogenetic properties, use of finasteride or other 5???±R inhibitors, or alopecia due to other causes. Men and women were instructed not to alter their hairstyle or dye their hair during the studies. Study protocols One initial, 6-months randomized, double-blind, placebo controlled studies were initiated, and both were continued as 1 consecutive, 6-months, double-bind, placebo-controlled extension studies. The objectives of the controlled extension studies were to determine the effect of long-term use of LDS 100, the effect of delaying treatment by one year, and the progression of MPHL in men and FPHL in women not receiving active treatment. 6-months initial studies Following a screening procedure, study subjects entered a 2 week, single-blind, placebo run-in period. All men and women received study shampoo (Claim 3S?®) for standardization of shampoo used and for prophylaxis of seborrheic dermatitis, which might affect scalp hair growth. Subjects (240 men and 80 women) were than randomized to LDS 100 (2 times for week, 20 minutes, 140 Hz) or placebo LDS 100 (no infrared light, 2 times for week, 20 minutes, 140 Hz) (1:1) for six months (Figs. 1 and 2). Men and women visited the clinic every 3 months, where they completed a hair growth questionnaire and investigators completed assessments of scalp hair growth. Every 6 months, photographs of scalp hair were taken for hair counts and for the expert panel assessments of hair growth. Reports of adverse events were collected throughout the studies. 6-months extension studies Men and women completing the initial 6-months, placebo controlled studies were eligible to enrol in one consecutive, 6-months, placebo-controlled extension studies. In these extension studies, men (N = 183) and women (N = 55) were randomly assigned (as determined at initial randomization) to treatment with either LDS 100 (2 times for week, 20 minutes, 140 Hz) or placebo LDS 100 (no infrared light, 2 times for week, 20 minutes, 140 Hz) (9:1), such that subjects were randomized to one of four groups that allocated treatment to them during both the initial 6-months studies and the 6-months extension studies: LDS 100 LDS 100, LDS 100 Placebo, Placebo LDS 100, or Placebo Placebo. The procedures for the 6-months extension studies were similar to those for the initial 6-months studies. Evaluation procedures Efficacy measurements Four predefined efficacy endpoints provided a comprehensive assessment of changes in scalp hair from baseline: (1) hair counts, obtained from color macrophotographs of a 1-inch diameter circular area (5.1 cm2) of clipped hair (length 1 mm), centered at the anterior leading edge of the vertex thinning area; (2) patient self-assessment of scalp hair, using a validated, self-administered hair growth questionnarie; (3) investigator assessment of scalp hair growth, using a standardized 7-point rating scale; (4) independent assessment of standardized clinical global photographs of the vertex scalp by a panel of dermatologists who were blinded to treatment and experienced in photagraphic assessment of hair growth, using the standardized 7-point rating scale. Safety measurements Safety measurements included clinical and laboratory evaluations, and adverse experience reports. Statistical analysis A data analysis, plan pre-specified all primary and secondary hypotheses, including combining data from the initial 6-months studies to improve precision of the estimates of the treatment effect, as well as from each of the 6-months controlled extensions due to the small size of the placebo groups in those studies. Hair counts were assessed by the difference between the count at each time point versus the baseline count, and mean hair count values for each treatment group were determined using SASTM Least Squares Means. Each of the seven questions in the patient self-assessment of hair growth was assessed separately, and the responses to each question at each time point were taken as assessments of changes from baseline. The investigator assessment of hair growth and the expert panel assessments of global photographs were assessed by comparison of mean rating scores for each tratment group at each time point, based on the 7-point rating scale (minimum value = -3.0 [greatly decreased]; maximum value = 3.0 [greatly increased]. Hypothesis testing for hair counts, individual patient self-assessment questions, and investigator and global photographic assessments was performed using analysis of variance. The primary efficacy analysis population for this report was the intention to treat population, which included all subjects with at least one day randomozed therapy and with both baseline and at least one post-baseline efficacy assessment. For all efficacy analyses, missing data were estimated by carring data forward from the previous visit. However, no data were carried forward from the baseline evaluation, or between the initial 6-months study and the 6-months extension study. A secondary population for analysis of efficacy included only the data from the cohort of subjects who completed the 1-year study. Safety analyses were based on all subjects with at least one day of randomized therapy. The safety analyses focused on the biochemical parameters, using analysis of variance, and on adverse experience reports. Results Patient accounting and baseline characteristics Patient accounting is summarized in Figure 1. A summary of baseline characteristics for man and women who entered the extension study (2nd 6-months) is presented by treatment group in Table I. Demographics and baseline caharacteristics were comparable among the four treatment groups. Hair counts In the group that received LDS 100 for all 12 months (LDS 100 LDS 100), there were significant increases in hair counts over 1 year (p < 0.001 versus baseline for all time points), which reached a maximal increase at month 6, declined somewhat thereafter but remained above baseline throughout, with a mean increase of hairs at month 12 (Fig. 3). In contrast, in the group that received placebo for all 12 months (Placebo Placebo), there was a progressive decline in hair counts over 1 year, culminating in a mean decrease from baseline of hairs at month 12 (Fig. 3). For the group crossed over from Placebo to LDS 100 after 6 months (Placebo LDS 100) there was a decrease in hair count during the months of placebo treatment. This initial loss of hair on placebo was followed by significant increases in hair count during treatment with LDS 100 through month 12 (Fig. 3). Increases in hair count during LDS 100 treatment in this group were generally sustained over time, although the increases compared to baseline were consistently less than those observed in the LDS 100 LDS 100 group at comparable time points, with the difference being similar in magnitude to the amount of hair loss sustained during the year of placebo treatment. For the group that received LDS 100 for 1st 6 months, was crossed over to placebo for 2nd 6 months (LDS 100 Placebo), the beneficial effect on hair count seen during the first 6-months of LDS 100 treatment was reversed after 6 months of placebo treatment (Fig. 3). Patient self-assessment For each of the seven questions in the patient self-assessment questionnaire, treatment with LDS 100 (LDS 100 LDS 100) was superior to treatment with placebo (Placebo Placebo) at each time point (p < 0.001 for all between-group comparisons). The LDS 100 LDS 100 group demonstrated significant (p < 0.001) improvement from baseline at each time point for each question, with the exception that there was no significant difference from baseline at the month 6 time point for Question 5a (assessment of satisfaction with appearance of the frontal hairline), where as the Placebo Placebo group generally demonstrated deterioration from baseline over time. For each of the seven questions, a greater proportion of LDS 100- versus placebo-trated subjects reported an improvement from baseline, with the difference between groups increasing over time (Table II). In the Placebo LDS 100 group, there was generally sustained improvement following 6 months of placebo treatment for each question during the period of LDS 100 treatment (p < 0.001), although, as with hair counts, this improvement was less than that seen in the LDS 100 LDS 100 group at comparable time points. For the LDS 100 Placebo group, partial to complete reversibility of the beneficial effect of LDS 100 was observed for six of the seven questions after 6 months of placebo treatment (2nd 6-months). Investigator assessment Based on the investigator assessment, treatment with LDS 100 (LDS 100 LDS 100) was superior to treatment with placebo (Placebo Placebo) at each time point (p < 0.001, all comparisons). The Placebo LDS 100 group showed improvement during the period of LDS 100 therapy, although as with hair counts and patient self-assessment the magnitude of this improvement was less than that seen in the LDS 100 LDS 100 group at comparable time points. For the LDS 100 Placebo group, there was initial improvement during the first year of LDS 100 treatment, followed by a plateau during the 6-months of placebo treatment. Global photographic assessment Based on the global photographic assessment, treatment with LDS 100 (LDS 100 LDS 100) was superior to treatment with placebo (Placebo Placebo) at each time point (p < 0.001, all comparisons). At month 12, 48% of LDS 100-treated subjects were rated as slightly, moderately, or greatly improved compared to 6% of placebo-treated subjects. Viewed in the context of maintaining visible hair from baseline, 90% of subjects treated with LDS 100 demonstrated no further visible hair loss by this assessment, compared to 25% of patients on placebo. Conversely, 75% of subjects treated with placebo demonstrated futher visible hair loss by this assessment at 1 year, compared to 10% of subjects on LDS 100 (Fig. 5). For the LDS 100 LDS 100 group, maximal improvement by global photographic assessment was observed at month 12. In contrast, the Placebo Placebo group demonstrated progressive worsening by global photographic assessment through month 12. The Placebo LDS 100 group also demonstrated sustained improvement in mean score during the period of LDS 100 treatment from month 6 to month 12 (p < 0.001), although, as with the three other efficacy measures, the magnitude of improvement was less than that seen in the LDS 100 LDS 100 group for comparable time points. For the Placebo LDS 100 group, the beneficial effect of LDS 100 was reversed after 6 months of placebo treatment (p < 0.001). Global photographs of representative subjects from the Placebo Placebo and LDS 100 LDS 100 groups who were rated by the expert panel as having decreased or increased hair growth from baseline are shown in Figure 6. Adverse Event Clinical adverse experiences that were considered by the investigator to be possibly or definitely treatment-related and that occurred in at least 1% of subjects are summarized in Table III. As reported previously, in the first 6-months a slightly higher proportion of LDS 100 than placebo subjects reported treatment-related adverse experiences related to itching and inflammation (Table III), discontinued the studies due these side effects. These side effects resolved after discontinuation and also resolved in most subjects who reported them but remained on therapy with LDS 100. The adverse experience profile for subjects continuing in the extension studies was similar to that of the initial studies (Table III). Discussion The data from this study and its long-term extension represent the longest reported controlled observations in men with MPHL and women with FPHL. The combined analysis demonstrated that long-term tretament with LDS 100 led to significant and durable improvements, compared to both baseline and placebo, in scalp hair in men with MPHL and in women with FPHL. Hair counts increased over the first 6-months of treatment with LDS 100, with improvement above baseline maintained over 1 year. In contrast, the placebo group progressively lost hair over 1 year, confirming the natural progression of hair loss in this disorder due to the conyinued miniaturization of scalp hair. Thus, the treatment effect of LDS 100 on hair count relative to placebo increased progressively over time, leading to a net improvement for LDS 100-treated subjects hairs compared to placebo at one year. Most (65%) LDS 100-treated subjects had increases in hair counts at one year, compared to none of the placebo-treated subjects, but even for those LDS 100-treated subjects with less hair by hair count at one year, the magnitude of loss was less than that observed in the placebo group. these data support that the progression of hair loss observed in placebo-treated subjects was significantly reduced by treatment with LDS 100. Based on the predefined endpoints utilizing photographic methods (hair counts, and global photographic assessment), peak efficacy was observed at 6 months to 12 months of treatment with LDS 100. This observation of an apparent peaking effect is likely due, in part, to the previously-reported beneficial effects of LDS 100 on the hair growth cycle based on a phototrichogram study. In that study, initiation of LDS 100 treatment was shown to increase the number of anagen-phase hairs and to increase the anagen to telogen ratio, consistent with normalization of the growth cycles of previously miniaturized hairs. Consistent with these results, LDS 100 treatment was also shown to increase the growth rate and/or thikness of hairs, based on analysis of serial hair weight measurements. Because these beneficial changes in the hair growth cycle are dependent on when therapy with LDS 100 is initiated and occur rapidly, the affected hairs are driven to cycle in a synchronous manner. If these hairs have somewhat similar anagen phase durations, they would enter telogen phase as the anagen (and catagen) phase ended, followed by subsequent shedding, in a partially synchronized fashion. This would be expected to produce a gradual decline from peak hair count after a period of time equal to the average anagen phase duration. Eventually, as subsequent growth cycles recurred, these hairs would be expected to become increasingly independent, thereby losing their synchronous character as their growth cycles further normalized over time, leading to a sustained increase in hair count at a plateau above baseline, as suggested by the 1 year data presented here. Patient self-assessment of hair growth provides a mechanism for each subject to judge the benefits of treatment under controlled and blinded conditions. This questionnaire asks specific questions about the patient's hair growth or loss and his degree of satisfaction with the appearance of his hair compared to study start. While a placebo effect was observed with this instrument, as is typical of patient questionnaire data, results consistently demonstrated that subjects treated with LDS 100 had a more positive self-assessment of their hair growth and satisfaction with their appearance than subjects treated with placebo, with the majority of LDS 100-treated subjects reporting satisfaction with the overall appearance of their scalp hair at 1 year. Consistent with the findings of another study in which LDS 100 was evaluated in subjects with predominantly frontal MPHL, patients' satisfaction with the appearance of their frontal hairline was improved by treatment with LDS 100 in the present study. The investigators' assessment are based on observations of subjects seen in the clinic and provide a clinically relevant assessment of the patient's hair growth or loss since study start. These assessments demonstrated a sustained benefit of LDS 100 treatment over 1 year. As with the patient self-assessment, the investigator assessment had a greater placebo effect than the more objective endpoints of hair count and global photographic assessment. Such an effect is not inusual in double-blind, placebo-control led studies, and is often due to general expectation bias on the part of the patient's treating physician. Despite this apparent placebo effect, the beneficial effects of LDS 100 were demonstrated by the clinical assessment made by the investigators in these studies. In contrast to the investigator assessment, the blinded comparison of paired pre- and post-treatment global photographs by the expert panel, which also assessed change from baseline, demonstrated minimal, if any, placebo effect. Based on this assessment, LDS 100 treatment led to maintenance of improvement above baseline in scalp hair growth and scalp coverage over one year, while placebo subjects progressively worsened. Treatment with LDS 100 for one year led to sustained protection against further visible hair loss in nearly all (90%) subjects, while further visible hair loss as evident in most (75%) subjects treated with placebo over the same time period. While the number of patients remaining in the study declined over time and the size of the placebo group was limited in the extension study, the results of analyses that included either all available patients at each time point or only the cohort of patients with data at month 12 were consistent and supported a sustained benefit in hair growth for subjects receiving LDS 100 compared with placebo. Additionally, examination of data from placebo-treated subjects in all cohorts demonstrated the continued loss of scalp hair that occurs in untreated subjects with MPHL and FPHL. Thus, regardless of the cohort examined, the long-term data from these studies consistently demonstrated a beneficial effect of LDS 100 compared with placebo for men with MPHL and women with FPHL. Moreover, this beneficial effect increased over time due to the progressive increase in the net treatment effect of LDS 100 compared with placebo. The safety data from the one year of controlled observations in the current study provide reassurance that long-term use of LDS 100 in men with MPHL and women with FPHL is not associated with an increase in the incidence of adverse experiences or any new safety concerns. A few subjects in the current studies experienced reversible itching and inflammation. No other significant adverse effects of LDS 100 were observed in the patient population evaluated in the current studies. This excellent safety profile of long-term use of LDS 100 is consistent with the experience with the infrared light at five times the dose used in the present study that has been well-documented in large clinical trials and post-marketing surveillance in men and women. In summary, treatment with LDS 100 over one year increased scalp hair as determined by scalp hair counts, patient self-assessment, investigator assessment, and global photographic assessment, when compared with placebo. In contrast, data from the placebo group confirmed that without treatment progressive reductions in hair count and continued loss of visible hair occurs. Long-term treatment with LDS 100 was generally well tolerated. The results of these studies demonstrate that chronic therapy with LDS 100 leads to durable improvements in hair growth in men with MPHL and women with FPHL and slows the further progression of hair loss that occurs without treatment. References 1. Arndt K.A., Noe I.M. et al.: Laser Therapy. Basic concepts and nomenclature. J. am. Acad. Dermatol. Dec. 1981, 5 2. Dwyer R.M., Bass M.: Laser Applications. Vol. III Monte Ross Ed. Academic press, N.Y., 1977. 3. Fine S., Klein E.: Interaction of laser radiation with biological system. Proceeding of the first Conference on Biologic effects of laser radiations. Fed. Proc., 24, 35, 1965. 4. Goldman L.: Effects of new laser systems on the skin. Arch. Dermat.., 108, 385, 1973. 5. Goldman L.: Applications of the Laser. Cleveland. Chemical Rubber Co., 1973. 6. IIda H., Takahara H., Kahehi H., Tateno Y., Mammoto M.: Fundamental studies on laser radiation therapy. Nippon Acta radiol., 1969, Jul., 29, 411-5. 7. Mester E., Ludany G., Sellyei M., Szende B., Tota J.: The stimulating effect of power laser rays on biological systems. Laser Rev., 1, 3, 1968. 8. Mester E. et al.: Experimental and clinical observations wih Laser. Panmin. Med., 13, 538, 1971. 9. Olsen EA: Androgenetic alopecia. In: Olsen EA, ed. Disorders of hair growth: diagnosis and treatment. New York: McGraw-Hill, Inc., 1994: 257-83. 10. Price VH: Testosterone metabolism in the skin. Arch. Dermatol. 1975; 111: 1496-502. 11. Wolbarsht M.L.: Laser applications in medicine and biology. Vol. 1-2 Plenum Press. N.Y., 1971/74. Table I. Baseline characteristics of subjects entering the extension study "I am an unpaid medical advisor to Lexington Int." The openion I hold is totally independent of the company and its my personal view, to which I stand by. I am a medical advisor to Lexington International and Hairmax. What ever I say is my personal opinion.
  19. Hi there I am sorry I missed lot of things. Actually I have a very busy practise but then I just got another study send to me by some one who aparently ad,mired my stance could be the laser guys "Bad Guys"...hmmmmmm JUST A POINT No body is claiming that LLLT is all you need. Its just an adjunct to the main treatment. anyway I am subbitting this to be reviewed by the "Good Guys" Long-term (1-year) experience with LDS 100 in the treatment of men and women with androgenetic alopecia Background. LDS 100 is indicated for the treatment of men and women with androgenetic alopecia (male pattern hair loss, MPHL and female pattern hair loss, FPHL). However, the long-term (> 1 year) efficacy of LDS 100 in this population has not been previously reported. Objectives. To assess the efficacy and safety of LDS 100 in men and women with androgenetic alopecia compared to treatment with placebo device over 1 year. Methods. In 6 months, 240 men with MPHL and 80 women with FPHL were randomized to receive LDS 100 treatment or placebo treatment. Men and women continued in up to 1 year, placebo controlled extension studies. Efficacy was evaluated by hair counts, patient and investigator assessments, and panel review of clinical photographs. Results. Treatment with LDS 100 led to durable improvements in scalp hair over 1 year (p < 0.001 versus placebo, all endpoints), while treatment with placebo led to progressive hair loss. LDS 100 was generally well tolerated and no new safety concerns were identified during long-term use. Conclusions. In men with MPHL and in women with FPHL, long-term treatment with LDS 100 over 1 year was well tolerated, led to durable improvements in scalp hair growth, and slowed the further progression of hair loss that occurred without treatment. Androgenetic alopecia (male pattern hair loss, MPHL and female pattern hair loss, FPHL) occurs in men and women with an inherited sensitivity to the effects of androgens on scalp hair. The disorder is characterized by loss of visible hair over areas of the scalp due to progressive miniaturization of hair follicles. MPHL does not occur in men whit genetic deficiency of the type 2 5???±-reductase (5???±R) enzyme, which converts testosterone (T) to dihydrotestosterone (DHT), implicating DHT in the pathogenesis of this condition. Of the two 5???±R isoenzymes in man, Type 1 predominates in sebaceous glands of the skin, including scalp, while Type 2 is present in hair follicles, as well as the prostate. In the androgenetic alopecia also occurs a reduction of the synthesis of the mRNA and the DNA with diminution of the cellular metabolism. Three streets of control of the hair growth exist: - steroid control (T, 5???±R, DHT); - metabolic control (blood circulation, glucose, ATP); - autocrine-paracrine control (HrGF - Hair Grow Factor). The infrared radiation of LDS 100 (940 nm) penetrates in depth. It transits without producing great photo-biological effects; if not there where it comes to be absorbed then in the interface between the epidermis and the dermis. The photo-biological bases of therapeutic use of infrared radiation re-engage themselves in a mechanism "fallen" on various structures. There is a photoreception at the mitochondrial level. The radiation is absorbed at the level of the respiratory chain (cytochromes, oxidase cytocrome, dehydrogenase flowin) with the consequent activation of the respiratory chain and further the activation of the NAD (nicotinamide adenine dinucleotide). At the cellular membrane level there is an increase in the activity of the enzyme Na/K ATPasis, which in turn acts on the flow of Ca+. At this point one has a transduction and an amplification of the stimulus in the cellular ambit, with the activation of the cyclical nucleotides which modulate the synthesis of the mRNA and the DNA. The final photo-response is the bio-stimulation at the various levels of the cellular metabolic structure. The biological activation spreads from cell to cell with chemical transmissions. The infrared light increases the cellular metabolism accompanied by an augmentation of the capillary vascular bed of the radiant zone with an increase also in the supply of oxygen. Studies in man with MPHL and women with FPHL showed that LDS 100 had utility in this disorder. Randomized placebo-controlled trials demonstrated that treatment whit LDS 100 produced significant improvements in scalp hair growth, slowed the further progression of hair loss that occurred without treatment and led to increased patient satisfaction with the appearance of their scalp hair. LDS 100 use is contraindicated in women when they are or may potentially be pregnant and in subjects with pace-maker or other metallic devices, or those with acute phlebitis, serious arterial hypertension, neurogical illnesses, heightened cardiopathy, dermatitis and dermatosis. Materials and methods Study population Men aged 18 to 50 years, whit mild to moderately severe vertex MPHL according to a modified Norwood/Hamilton classification scale (II vertex, III vertex, IV or V), were enrolled. Women aged 18 to 50 years, with mild to moderately severe vertex FPHL according to a Ludwig classification scale (I, II or III), were enrolled. Principal exclusion criteria included significant abnormalities on screening physical examination or laboratory evaluation, surgical correction of scalp hair loss, topical Minoxidil use within one-year, use of drugs with androgenetic or antiandrogenetic properties, use of finasteride or other 5???±R inhibitors, or alopecia due to other causes. Men and women were instructed not to alter their hairstyle or dye their hair during the studies. Study protocols One initial, 6-months randomized, double-blind, placebo controlled studies were initiated, and both were continued as 1 consecutive, 6-months, double-bind, placebo-controlled extension studies. The objectives of the controlled extension studies were to determine the effect of long-term use of LDS 100, the effect of delaying treatment by one year, and the progression of MPHL in men and FPHL in women not receiving active treatment. 6-months initial studies Following a screening procedure, study subjects entered a 2 week, single-blind, placebo run-in period. All men and women received study shampoo (Claim 3S?®) for standardization of shampoo used and for prophylaxis of seborrheic dermatitis, which might affect scalp hair growth. Subjects (240 men and 80 women) were than randomized to LDS 100 (2 times for week, 20 minutes, 140 Hz) or placebo LDS 100 (no infrared light, 2 times for week, 20 minutes, 140 Hz) (1:1) for six months (Figs. 1 and 2). Men and women visited the clinic every 3 months, where they completed a hair growth questionnaire and investigators completed assessments of scalp hair growth. Every 6 months, photographs of scalp hair were taken for hair counts and for the expert panel assessments of hair growth. Reports of adverse events were collected throughout the studies. 6-months extension studies Men and women completing the initial 6-months, placebo controlled studies were eligible to enrol in one consecutive, 6-months, placebo-controlled extension studies. In these extension studies, men (N = 183) and women (N = 55) were randomly assigned (as determined at initial randomization) to treatment with either LDS 100 (2 times for week, 20 minutes, 140 Hz) or placebo LDS 100 (no infrared light, 2 times for week, 20 minutes, 140 Hz) (9:1), such that subjects were randomized to one of four groups that allocated treatment to them during both the initial 6-months studies and the 6-months extension studies: LDS 100 LDS 100, LDS 100 Placebo, Placebo LDS 100, or Placebo Placebo. The procedures for the 6-months extension studies were similar to those for the initial 6-months studies. Evaluation procedures Efficacy measurements Four predefined efficacy endpoints provided a comprehensive assessment of changes in scalp hair from baseline: (1) hair counts, obtained from color macrophotographs of a 1-inch diameter circular area (5.1 cm2) of clipped hair (length 1 mm), centered at the anterior leading edge of the vertex thinning area; (2) patient self-assessment of scalp hair, using a validated, self-administered hair growth questionnarie; (3) investigator assessment of scalp hair growth, using a standardized 7-point rating scale; (4) independent assessment of standardized clinical global photographs of the vertex scalp by a panel of dermatologists who were blinded to treatment and experienced in photagraphic assessment of hair growth, using the standardized 7-point rating scale. Safety measurements Safety measurements included clinical and laboratory evaluations, and adverse experience reports. Statistical analysis A data analysis, plan pre-specified all primary and secondary hypotheses, including combining data from the initial 6-months studies to improve precision of the estimates of the treatment effect, as well as from each of the 6-months controlled extensions due to the small size of the placebo groups in those studies. Hair counts were assessed by the difference between the count at each time point versus the baseline count, and mean hair count values for each treatment group were determined using SASTM Least Squares Means. Each of the seven questions in the patient self-assessment of hair growth was assessed separately, and the responses to each question at each time point were taken as assessments of changes from baseline. The investigator assessment of hair growth and the expert panel assessments of global photographs were assessed by comparison of mean rating scores for each tratment group at each time point, based on the 7-point rating scale (minimum value = -3.0 [greatly decreased]; maximum value = 3.0 [greatly increased]. Hypothesis testing for hair counts, individual patient self-assessment questions, and investigator and global photographic assessments was performed using analysis of variance. The primary efficacy analysis population for this report was the intention to treat population, which included all subjects with at least one day randomozed therapy and with both baseline and at least one post-baseline efficacy assessment. For all efficacy analyses, missing data were estimated by carring data forward from the previous visit. However, no data were carried forward from the baseline evaluation, or between the initial 6-months study and the 6-months extension study. A secondary population for analysis of efficacy included only the data from the cohort of subjects who completed the 1-year study. Safety analyses were based on all subjects with at least one day of randomized therapy. The safety analyses focused on the biochemical parameters, using analysis of variance, and on adverse experience reports. Results Patient accounting and baseline characteristics Patient accounting is summarized in Figure 1. A summary of baseline characteristics for man and women who entered the extension study (2nd 6-months) is presented by treatment group in Table I. Demographics and baseline caharacteristics were comparable among the four treatment groups. Hair counts In the group that received LDS 100 for all 12 months (LDS 100 LDS 100), there were significant increases in hair counts over 1 year (p < 0.001 versus baseline for all time points), which reached a maximal increase at month 6, declined somewhat thereafter but remained above baseline throughout, with a mean increase of hairs at month 12 (Fig. 3). In contrast, in the group that received placebo for all 12 months (Placebo Placebo), there was a progressive decline in hair counts over 1 year, culminating in a mean decrease from baseline of hairs at month 12 (Fig. 3). For the group crossed over from Placebo to LDS 100 after 6 months (Placebo LDS 100) there was a decrease in hair count during the months of placebo treatment. This initial loss of hair on placebo was followed by significant increases in hair count during treatment with LDS 100 through month 12 (Fig. 3). Increases in hair count during LDS 100 treatment in this group were generally sustained over time, although the increases compared to baseline were consistently less than those observed in the LDS 100 LDS 100 group at comparable time points, with the difference being similar in magnitude to the amount of hair loss sustained during the year of placebo treatment. For the group that received LDS 100 for 1st 6 months, was crossed over to placebo for 2nd 6 months (LDS 100 Placebo), the beneficial effect on hair count seen during the first 6-months of LDS 100 treatment was reversed after 6 months of placebo treatment (Fig. 3). Patient self-assessment For each of the seven questions in the patient self-assessment questionnaire, treatment with LDS 100 (LDS 100 LDS 100) was superior to treatment with placebo (Placebo Placebo) at each time point (p < 0.001 for all between-group comparisons). The LDS 100 LDS 100 group demonstrated significant (p < 0.001) improvement from baseline at each time point for each question, with the exception that there was no significant difference from baseline at the month 6 time point for Question 5a (assessment of satisfaction with appearance of the frontal hairline), where as the Placebo Placebo group generally demonstrated deterioration from baseline over time. For each of the seven questions, a greater proportion of LDS 100- versus placebo-trated subjects reported an improvement from baseline, with the difference between groups increasing over time (Table II). In the Placebo LDS 100 group, there was generally sustained improvement following 6 months of placebo treatment for each question during the period of LDS 100 treatment (p < 0.001), although, as with hair counts, this improvement was less than that seen in the LDS 100 LDS 100 group at comparable time points. For the LDS 100 Placebo group, partial to complete reversibility of the beneficial effect of LDS 100 was observed for six of the seven questions after 6 months of placebo treatment (2nd 6-months). Investigator assessment Based on the investigator assessment, treatment with LDS 100 (LDS 100 LDS 100) was superior to treatment with placebo (Placebo Placebo) at each time point (p < 0.001, all comparisons). The Placebo LDS 100 group showed improvement during the period of LDS 100 therapy, although as with hair counts and patient self-assessment the magnitude of this improvement was less than that seen in the LDS 100 LDS 100 group at comparable time points. For the LDS 100 Placebo group, there was initial improvement during the first year of LDS 100 treatment, followed by a plateau during the 6-months of placebo treatment. Global photographic assessment Based on the global photographic assessment, treatment with LDS 100 (LDS 100 LDS 100) was superior to treatment with placebo (Placebo Placebo) at each time point (p < 0.001, all comparisons). At month 12, 48% of LDS 100-treated subjects were rated as slightly, moderately, or greatly improved compared to 6% of placebo-treated subjects. Viewed in the context of maintaining visible hair from baseline, 90% of subjects treated with LDS 100 demonstrated no further visible hair loss by this assessment, compared to 25% of patients on placebo. Conversely, 75% of subjects treated with placebo demonstrated futher visible hair loss by this assessment at 1 year, compared to 10% of subjects on LDS 100 (Fig. 5). For the LDS 100 LDS 100 group, maximal improvement by global photographic assessment was observed at month 12. In contrast, the Placebo Placebo group demonstrated progressive worsening by global photographic assessment through month 12. The Placebo LDS 100 group also demonstrated sustained improvement in mean score during the period of LDS 100 treatment from month 6 to month 12 (p < 0.001), although, as with the three other efficacy measures, the magnitude of improvement was less than that seen in the LDS 100 LDS 100 group for comparable time points. For the Placebo LDS 100 group, the beneficial effect of LDS 100 was reversed after 6 months of placebo treatment (p < 0.001). Global photographs of representative subjects from the Placebo Placebo and LDS 100 LDS 100 groups who were rated by the expert panel as having decreased or increased hair growth from baseline are shown in Figure 6. Adverse Event Clinical adverse experiences that were considered by the investigator to be possibly or definitely treatment-related and that occurred in at least 1% of subjects are summarized in Table III. As reported previously, in the first 6-months a slightly higher proportion of LDS 100 than placebo subjects reported treatment-related adverse experiences related to itching and inflammation (Table III), discontinued the studies due these side effects. These side effects resolved after discontinuation and also resolved in most subjects who reported them but remained on therapy with LDS 100. The adverse experience profile for subjects continuing in the extension studies was similar to that of the initial studies (Table III). Discussion The data from this study and its long-term extension represent the longest reported controlled observations in men with MPHL and women with FPHL. The combined analysis demonstrated that long-term tretament with LDS 100 led to significant and durable improvements, compared to both baseline and placebo, in scalp hair in men with MPHL and in women with FPHL. Hair counts increased over the first 6-months of treatment with LDS 100, with improvement above baseline maintained over 1 year. In contrast, the placebo group progressively lost hair over 1 year, confirming the natural progression of hair loss in this disorder due to the conyinued miniaturization of scalp hair. Thus, the treatment effect of LDS 100 on hair count relative to placebo increased progressively over time, leading to a net improvement for LDS 100-treated subjects hairs compared to placebo at one year. Most (65%) LDS 100-treated subjects had increases in hair counts at one year, compared to none of the placebo-treated subjects, but even for those LDS 100-treated subjects with less hair by hair count at one year, the magnitude of loss was less than that observed in the placebo group. these data support that the progression of hair loss observed in placebo-treated subjects was significantly reduced by treatment with LDS 100. Based on the predefined endpoints utilizing photographic methods (hair counts, and global photographic assessment), peak efficacy was observed at 6 months to 12 months of treatment with LDS 100. This observation of an apparent peaking effect is likely due, in part, to the previously-reported beneficial effects of LDS 100 on the hair growth cycle based on a phototrichogram study. In that study, initiation of LDS 100 treatment was shown to increase the number of anagen-phase hairs and to increase the anagen to telogen ratio, consistent with normalization of the growth cycles of previously miniaturized hairs. Consistent with these results, LDS 100 treatment was also shown to increase the growth rate and/or thikness of hairs, based on analysis of serial hair weight measurements. Because these beneficial changes in the hair growth cycle are dependent on when therapy with LDS 100 is initiated and occur rapidly, the affected hairs are driven to cycle in a synchronous manner. If these hairs have somewhat similar anagen phase durations, they would enter telogen phase as the anagen (and catagen) phase ended, followed by subsequent shedding, in a partially synchronized fashion. This would be expected to produce a gradual decline from peak hair count after a period of time equal to the average anagen phase duration. Eventually, as subsequent growth cycles recurred, these hairs would be expected to become increasingly independent, thereby losing their synchronous character as their growth cycles further normalized over time, leading to a sustained increase in hair count at a plateau above baseline, as suggested by the 1 year data presented here. Patient self-assessment of hair growth provides a mechanism for each subject to judge the benefits of treatment under controlled and blinded conditions. This questionnaire asks specific questions about the patient's hair growth or loss and his degree of satisfaction with the appearance of his hair compared to study start. While a placebo effect was observed with this instrument, as is typical of patient questionnaire data, results consistently demonstrated that subjects treated with LDS 100 had a more positive self-assessment of their hair growth and satisfaction with their appearance than subjects treated with placebo, with the majority of LDS 100-treated subjects reporting satisfaction with the overall appearance of their scalp hair at 1 year. Consistent with the findings of another study in which LDS 100 was evaluated in subjects with predominantly frontal MPHL, patients' satisfaction with the appearance of their frontal hairline was improved by treatment with LDS 100 in the present study. The investigators' assessment are based on observations of subjects seen in the clinic and provide a clinically relevant assessment of the patient's hair growth or loss since study start. These assessments demonstrated a sustained benefit of LDS 100 treatment over 1 year. As with the patient self-assessment, the investigator assessment had a greater placebo effect than the more objective endpoints of hair count and global photographic assessment. Such an effect is not inusual in double-blind, placebo-control led studies, and is often due to general expectation bias on the part of the patient's treating physician. Despite this apparent placebo effect, the beneficial effects of LDS 100 were demonstrated by the clinical assessment made by the investigators in these studies. In contrast to the investigator assessment, the blinded comparison of paired pre- and post-treatment global photographs by the expert panel, which also assessed change from baseline, demonstrated minimal, if any, placebo effect. Based on this assessment, LDS 100 treatment led to maintenance of improvement above baseline in scalp hair growth and scalp coverage over one year, while placebo subjects progressively worsened. Treatment with LDS 100 for one year led to sustained protection against further visible hair loss in nearly all (90%) subjects, while further visible hair loss as evident in most (75%) subjects treated with placebo over the same time period. While the number of patients remaining in the study declined over time and the size of the placebo group was limited in the extension study, the results of analyses that included either all available patients at each time point or only the cohort of patients with data at month 12 were consistent and supported a sustained benefit in hair growth for subjects receiving LDS 100 compared with placebo. Additionally, examination of data from placebo-treated subjects in all cohorts demonstrated the continued loss of scalp hair that occurs in untreated subjects with MPHL and FPHL. Thus, regardless of the cohort examined, the long-term data from these studies consistently demonstrated a beneficial effect of LDS 100 compared with placebo for men with MPHL and women with FPHL. Moreover, this beneficial effect increased over time due to the progressive increase in the net treatment effect of LDS 100 compared with placebo. The safety data from the one year of controlled observations in the current study provide reassurance that long-term use of LDS 100 in men with MPHL and women with FPHL is not associated with an increase in the incidence of adverse experiences or any new safety concerns. A few subjects in the current studies experienced reversible itching and inflammation. No other significant adverse effects of LDS 100 were observed in the patient population evaluated in the current studies. This excellent safety profile of long-term use of LDS 100 is consistent with the experience with the infrared light at five times the dose used in the present study that has been well-documented in large clinical trials and post-marketing surveillance in men and women. In summary, treatment with LDS 100 over one year increased scalp hair as determined by scalp hair counts, patient self-assessment, investigator assessment, and global photographic assessment, when compared with placebo. In contrast, data from the placebo group confirmed that without treatment progressive reductions in hair count and continued loss of visible hair occurs. Long-term treatment with LDS 100 was generally well tolerated. The results of these studies demonstrate that chronic therapy with LDS 100 leads to durable improvements in hair growth in men with MPHL and women with FPHL and slows the further progression of hair loss that occurs without treatment. References 1. Arndt K.A., Noe I.M. et al.: Laser Therapy. Basic concepts and nomenclature. J. am. Acad. Dermatol. Dec. 1981, 5 2. Dwyer R.M., Bass M.: Laser Applications. Vol. III Monte Ross Ed. Academic press, N.Y., 1977. 3. Fine S., Klein E.: Interaction of laser radiation with biological system. Proceeding of the first Conference on Biologic effects of laser radiations. Fed. Proc., 24, 35, 1965. 4. Goldman L.: Effects of new laser systems on the skin. Arch. Dermat.., 108, 385, 1973. 5. Goldman L.: Applications of the Laser. Cleveland. Chemical Rubber Co., 1973. 6. IIda H., Takahara H., Kahehi H., Tateno Y., Mammoto M.: Fundamental studies on laser radiation therapy. Nippon Acta radiol., 1969, Jul., 29, 411-5. 7. Mester E., Ludany G., Sellyei M., Szende B., Tota J.: The stimulating effect of power laser rays on biological systems. Laser Rev., 1, 3, 1968. 8. Mester E. et al.: Experimental and clinical observations wih Laser. Panmin. Med., 13, 538, 1971. 9. Olsen EA: Androgenetic alopecia. In: Olsen EA, ed. Disorders of hair growth: diagnosis and treatment. New York: McGraw-Hill, Inc., 1994: 257-83. 10. Price VH: Testosterone metabolism in the skin. Arch. Dermatol. 1975; 111: 1496-502. 11. Wolbarsht M.L.: Laser applications in medicine and biology. Vol. 1-2 Plenum Press. N.Y., 1971/74. Table I. Baseline characteristics of subjects entering the extension study "I am an unpaid medical advisor to Lexington Int." The openion I hold is totally independent of the company and its my personal view, to which I stand by.
  20. OK fair enough Do you think ISHRS that press release is wrong as well? If you are saying that then OK. I will basically stop here, I will probably keep your video in mind but will also keep my own view, which is basd on doctors like yourself.
  21. by brand new thread I meant , it was for me the first time to come across it. Having said this. ISHRS is a non biased body of Doctors, It conducts the scientific meetings and all the study that are done for furthering the cause of Hair transplant is done under the forum of ISHRS. This Forum is a forum for the patients and the doctors to inter act between each other across the globe and discuss the issues. It certainly can be important for the patients so that they can choose the doctors but it certainly does not mean it is more imporatnt than ISHRS. I agree that being the member of ISHRS does not mean that you are good or bad, it does mean one thing that you are a registered physician with giverning body, some rules are applied. At the end of the day, every one is responsible for their own actions. It was due to ISHRS that new technology was evolved. Doctors like H&W came into light. Dr Shiparo and others also improved the hair lines, microscopes were introduced and a healthy competition started. Every one has triedto bring new and new techniques. SO please do not try to under mine or compare the two forums, they are different. I am sure Dr Feller will also agree to me over here and so would Bill.
  22. The word "CURE" means to remove the problem, like if some one suffereing from Malaria it si cured with Medicine We do not cure baldness we manage baldness Management means when we can use a replacement from outside or inside body to tackle problem Diabetis is Managed with medicine like insulin Hair transplant is how we manage the baldness but we can cure baldness a it will never stop at all. Its a progressive condition. This is my personal openion May be once we do the gene manipulation and once and for all stop hair loss than that would be a cure.
  23. Dear Lorenzo I think I have told the community that I did not intentially hide my affiliation, I did not took the name of Lexington directly unless was unavoidable or so. I am a non-paid medical advisor, that means they were looking for a doctor to support their idea and as I was doing that, they asked me if they can add my name and I agreed. I still agree that it was my fault but that I guess should not be a major crime. As far as my point of view is concern Please read.... ISHRS Press Release Low-Level Laser Therapy is Now a Do-It-Yourself Hair Loss Treatment NEW YORK (October 16, 2003)- While lasers are best known as high-energy beams of coherent light that can cut through a variety of materials including human tissue, low-energy laser light has been found to be capable of modulating beneficial biologic effects in human, animal and plant cells. The biomodulating effects of low-level laser light on human cells has been adapted to medical uses such as enhanced wound healing and treatment of some types of pain, and to cosmetic uses associated with effects on human skin. Low-level laser light has also been found to have biomodulating effects on human hair and hair follicles. The effectiveness of low-level laser light in hair restoration was described today by Martin Unger, MD, Toronto, Canada, in a presentation at the 11th Annual Meeting of the International Society of Hair Restoration Surgery (ISHRS). The ISHRS is meeting October 15-19, 2003, at the Marriott Marquis Hotel, New York City. Clinical studies have shown that low-level laser light is effective both cosmetically and physiologically in hair restoration, Dr. Unger said. The cosmetic effects include improvements in hair sheen and strength, characteristics that enhance the perception of "fullness" in overall hair appearance. Physiologic effects on hair follicles observed in both men and women include (1) prevention of hair loss, and (2) stimulation of hair regrowth in areas of hair loss. Dr. Unger, a physician hair restoration specialist, is medical director of a firm that makes a hand-held low-level laser therapy device for home use in hair restoration (HairMAX LaserComb, Lexington International, Boca Raton, FL). The device is accepted as a Medical Device in Canada, and advertising is allowed to make therapeutic claims that it (1) increases strength of scalp hair in men and women, (2) prevents scalp hair loss in men and women, and (3) causes regrowth of scalp hair in men and women. In the United States it is accepted by the Food and Drug Administration (FDA) for use as a Cosmetic Laser Product. Approval by the FDA as a Medical Device is pending while appropriate clinical trials are completed. The device is also sold in other countries outside North America. Low-level laser medical therapy is currently approved by the FDA for treatment of carpal tunnel syndrome and for relief of discomfort, Dr. Unger said. The device described by Dr. Unger is a hand-held, wand-like instrument with laser-light ports arranged across its surface like the teeth of a comb. Laser light in the visible red light spectrum is generated in a laser diode. The energy level is far below that of laser beams that cut or burn tissue. Rather, the low-level red laser light has a very low absorption rate in human tissue. Low-level laser therapy for hair restoration is also delivered in a hood-like device that fits over a patient's head much like a hair dryer in a beauty salon. The mechanism of action of low-level laser light on human cells is not completely understood. The interaction of laser light with cells has the basic feature of modulating cell behavior without causing significant temperature increase inside the cells; higher-energy lasers used to treat some types of cancer destroy cancer cells by heating them from the inside. A resulting photochemical reaction inside cells treated with low-level laser light may alter physical and chemical properties of molecules important to cellular activities. Two of the most significant effects of low-level laser light in wound healing and in pain control, Dr. Unger said, are improved arterial and venous blood flow and decreased inflammation. The effects of low-level laser light associated with its effects of hair and hair follicles are not known with precision. In clinical trials, 97% of patients have had some benefit in improvement of hair characteristics, stabilization of hair loss, or hair regrowth, Dr. Unger said. Hair regrowth is defined by Dr. Unger and colleagues as an increase of hair count of 11% or more from baseline count. In the most recently conducted FDA clinical trials of the device, patients studied were men and women with thinning hair in the scalp area. The patients received two low-level laser light treatments per week over a six-month period. Results have shown: 100% of men had stabilization of hair loss in frontal and vertex (top of the head) areas; 84.6% of men had hair regrowth (11% of more from baseline) in the frontal area; 82.8% of men had hair regrowth (11% or more from baseline) in the vertex area; 87.5% of women had stabilization of hair loss in the frontal area; 100% of women had stabilization of hair loss in the vertex area; 75% of women had hair regrowth (11% or more from baseline) in the frontal area; and, 96.4% of women had hair regrowth (11% or more from baseline) in the vertex area. No side effects of low-level laser therapy have been observed, Dr. Unger said. There have been no reports of eye damage from exposure to low-level laser light. Patients with medical conditions such as a history of skin cancer, persistent scalp infections, and photosensitivity to laser light were excluded from the study. The ISHRS is the world's largest not-for-profit professional organization in the field of hair restoration surgery, with 512 physician members in 45 countries. The organization was founded in 1992 to promote the enhancement of the specialty of hair restoration surgery through education, information-sharing, and observance of ethical standards.
  24. ISHRS Press Release Low-Level Laser Therapy is Now a Do-It-Yourself Hair Loss Treatment NEW YORK (October 16, 2003)- While lasers are best known as high-energy beams of coherent light that can cut through a variety of materials including human tissue, low-energy laser light has been found to be capable of modulating beneficial biologic effects in human, animal and plant cells. The biomodulating effects of low-level laser light on human cells has been adapted to medical uses such as enhanced wound healing and treatment of some types of pain, and to cosmetic uses associated with effects on human skin. Low-level laser light has also been found to have biomodulating effects on human hair and hair follicles. The effectiveness of low-level laser light in hair restoration was described today by Martin Unger, MD, Toronto, Canada, in a presentation at the 11th Annual Meeting of the International Society of Hair Restoration Surgery (ISHRS). The ISHRS is meeting October 15-19, 2003, at the Marriott Marquis Hotel, New York City. Clinical studies have shown that low-level laser light is effective both cosmetically and physiologically in hair restoration, Dr. Unger said. The cosmetic effects include improvements in hair sheen and strength, characteristics that enhance the perception of "fullness" in overall hair appearance. Physiologic effects on hair follicles observed in both men and women include (1) prevention of hair loss, and (2) stimulation of hair regrowth in areas of hair loss. Dr. Unger, a physician hair restoration specialist, is medical director of a firm that makes a hand-held low-level laser therapy device for home use in hair restoration (HairMAX LaserComb, Lexington International, Boca Raton, FL). The device is accepted as a Medical Device in Canada, and advertising is allowed to make therapeutic claims that it (1) increases strength of scalp hair in men and women, (2) prevents scalp hair loss in men and women, and (3) causes regrowth of scalp hair in men and women. In the United States it is accepted by the Food and Drug Administration (FDA) for use as a Cosmetic Laser Product. Approval by the FDA as a Medical Device is pending while appropriate clinical trials are completed. The device is also sold in other countries outside North America. Low-level laser medical therapy is currently approved by the FDA for treatment of carpal tunnel syndrome and for relief of discomfort, Dr. Unger said. The device described by Dr. Unger is a hand-held, wand-like instrument with laser-light ports arranged across its surface like the teeth of a comb. Laser light in the visible red light spectrum is generated in a laser diode. The energy level is far below that of laser beams that cut or burn tissue. Rather, the low-level red laser light has a very low absorption rate in human tissue. Low-level laser therapy for hair restoration is also delivered in a hood-like device that fits over a patient's head much like a hair dryer in a beauty salon. The mechanism of action of low-level laser light on human cells is not completely understood. The interaction of laser light with cells has the basic feature of modulating cell behavior without causing significant temperature increase inside the cells; higher-energy lasers used to treat some types of cancer destroy cancer cells by heating them from the inside. A resulting photochemical reaction inside cells treated with low-level laser light may alter physical and chemical properties of molecules important to cellular activities. Two of the most significant effects of low-level laser light in wound healing and in pain control, Dr. Unger said, are improved arterial and venous blood flow and decreased inflammation. The effects of low-level laser light associated with its effects of hair and hair follicles are not known with precision. In clinical trials, 97% of patients have had some benefit in improvement of hair characteristics, stabilization of hair loss, or hair regrowth, Dr. Unger said. Hair regrowth is defined by Dr. Unger and colleagues as an increase of hair count of 11% or more from baseline count. In the most recently conducted FDA clinical trials of the device, patients studied were men and women with thinning hair in the scalp area. The patients received two low-level laser light treatments per week over a six-month period. Results have shown: 100% of men had stabilization of hair loss in frontal and vertex (top of the head) areas; 84.6% of men had hair regrowth (11% of more from baseline) in the frontal area; 82.8% of men had hair regrowth (11% or more from baseline) in the vertex area; 87.5% of women had stabilization of hair loss in the frontal area; 100% of women had stabilization of hair loss in the vertex area; 75% of women had hair regrowth (11% or more from baseline) in the frontal area; and, 96.4% of women had hair regrowth (11% or more from baseline) in the vertex area. No side effects of low-level laser therapy have been observed, Dr. Unger said. There have been no reports of eye damage from exposure to low-level laser light. Patients with medical conditions such as a history of skin cancer, persistent scalp infections, and photosensitivity to laser light were excluded from the study. The ISHRS is the world's largest not-for-profit professional organization in the field of hair restoration surgery, with 512 physician members in 45 countries. The organization was founded in 1992 to promote the enhancement of the specialty of hair restoration surgery through education, information-sharing, and observance of ethical standards.
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