LLLT patients from brouchere named Cosmetic Headlines

[hairthere]

ANYWAY, I have though to do a study on this and see for my self if it works.

 

you are already selling this product without knowing if it truly works, doctor. your logic is quite backwards.

[Dr. Alan Feller]

I would like to make an appeal to any and all LLLT proponents.

 

Please chime in on this thread and answer the questions brought up by the public and myself. Not the least of which is how a laser can affect hair follicles when by the time it makes it that deep into the dermis it has the same properties as a red lightbulb?

 

This is an excellent place to make your case and pick up thousands of new leads for the sale of your products and services. Join the discussion and show us where we're wrong please.

 

Thank you.

[nm76]

For what its worth , I have visited Dr Mohmand's clinic for a consult on a possible hair transplant. During my meeting, I was told about the various non surgical treatments out there. Mentioned after propecia and minox, was the the laser comb. That said, in no way was I made to believe that the laser comb was the cure to my hair loss woes. It was never recommended to me to use it after my transplant - it was just something that was mentioned as part of the meeting. What I was told was that if I do nothing to combat mpb, I should expect further surgeries to address future hair loss - nothing like, well if you do not use the comb after the HT you will be screwed, so buy the comb - we highly recommend it.

My point here is, that, the environment was completely different to that of the sales focused company I work for. Wherein IT solutions are pushed, just for the of sake of meeting numbers - rather than whether it addresses the pain points of a customer - these solutions are then left to rot in the boxes of media they were delivered in.

 

Dr Alan and others, sorry I cannot add something constructive to this conversation - the only comb I know of is the one I use to comb what hair I have left. That said, would I use the laser comb - probably not, but for the same reasons I would not use propecia or minox (my loss i guess).

 

That said, I've side tracked - My point here really is, we all as hair loss sufferers want to find something desperately that helps us - unfortunately there are people out there who take advantage of this. Yet at the same time there are others who in this quest are perhaps blinded by what the reality really is. I suppose I am guilty of this - I perform a certain scalp exercise which I believe has helped slow down my hair loss. Even though its effectiveness has not been proved by any medical studies or photo albums. I just believe it has worked to some extent - I still have hair, that is enough for me.

 

-nm76

[Dr. Alan Feller]

nm76,

You have added something constructive and I really appreicate you posting on this thread.

 

I don't think anyone accused your doctor of using high pressure tactics to sell anything, so there's no problem there. Whether he or any other LLLT doctor makes money off of LLLT is of no concern to me as long as they are being intellectually honest.

 

The focus of the LLLT threads was for an LLLT doctor to account for the many issues confronting LLLT to date such as:

1. There are no valid and believable before/after photos presented by the industy.

2. There are no valid and bellievable before/after photos presented by LLLT doctors. And this includes not only your own, but the doctors who actually performed the laser studies your doctor relied upon exclusively.

3. That laser light does not reach the follicle as laser light as required by proponents of LLLT. A serious flaw in the foundation of their theory. Just read the hairmax site where they state several times that it is the laser property of light that is the "active ingredient" behind the efficay of their product.

4. That while laymen are certainly welcome to believe what they will, doctors should hold themselves to a higher standard.

 

I think we all do what we have to do to make ourselves feel good and fulfilled. I have no problem with this. BUT when this tendency is the sole reason for a doctor to offer a remedy for money, then the water gets a bit muddied.

 

It's important the public be given BOTH sides of the issue, not just one. Unfortunately, the LLLT camp has a rich treasury and very aggressive marketing on it's side.

[Bill - Seemiller]

Dr. Mohmand,

 

You have a profile listed on Hairmax's website with a link to yours. So whether or not you receive any monetary compensation, this in itself is valuable to you.

 

You also mentioned on another thread that you make a little bit of money selling laser combs.

 

Therefore, please follow the terms of service as listed at the bottom of this forum and add your affiliation with Hairmax in your signature. However, please do not link to their website.

 

Understand that the issue is not whether or not you receive any compensation from Hairmax. It's about disclosure.

 

Please also address this community's concerns regarding why you didn't acknowledge your affiliation with Hairmax prior to getting involved in the debate.

 

Additionally, you are welcome to call Dr. Parsely or anyone else to join in this conversation. I too would like to hear other physician input and their views.

 

Best wishes,

 

Bill

[Dr. Mohammad Humayun Mohma]

That little bit money is about 5 US$ or may be 10US$. This is only to cover the cost of my packing etc as I mentioned.

 

I did acknowledge that It was a mistake that I did not disclose but I never took the name of the company, having said that

 

I would like to bring the other thread into the notice of the community that showed that ISHRS has also given its openion that 11% improvement is there with LLLT.

 

Now what will Dr Feller say about that.

 

Donot tell me if he would say except him all other doctors are mad and unethical.

 

What about he is not seeing the broader picture?

What about he has some illusion about the physics thats not there

 

His idea that LASER when touch any tissue becomes a normal light is so wrong

 

It was a normal light to stat with, LASER is never supposed to pass through a tissue, it is suppose to be absorbed to the depth depending on the wave length and pulse.

 

Cold and hot laser is because of the enery that is imparted.

 

I would encourage DR Feller and other members to go and learn about the study that has been given by ISHRS.

 

In the mean while I will try to conduct my own study.

 

JUST to educate the forum and I hope DR Feller the only doctor against the LLLT will say that

 

we as doctors cannot do all the studies ourselves, we ave to believe the studies other doctors have done and published, we can or cannot agree with them but then we have to prove clinically not theoretically.

 

If I say " I have been advoacting LLLT, that was based on other reputable doctors studies, now when I say I will conduct mine is based on the controversy." I will try to have a greater number and proper double blind study.

 

I thank my patients who has atleast shown my impartiality about the option give for LLLT.

[Dr. Mohammad Humayun Mohma]

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.

[Dr. Alan Feller]

Dr. Mohmand,

I am not the only doctor who oppoese the theories and supposed efficacy of Low Light Laser Therapy (LLLT), I am just the most vocal.

 

As for the question Dr. Rassman asked during the ISHRS LLLT presentation that you mentioned. It was not a question at all. I just called him today and he told me that he had commented on a MISTAKE in the LLLT data that he had noticed. That's a far cry from the way you mis-represented Dr. Rassman's involvement.

 

For the record, and I have his permission to say this, Dr. Rassman is OPPOSED to LLLT and sees it as I do, a quack therapy.

 

As most HT veterans know, Dr. Rassman is a true pioneer in the HT industry and has been open and transparent about what he does and why he does it during his entire career. He has been published more than any other HT doctor I know and has proven his own theories by showing RESULTS- which is far more than I can say for the LLLT industry. Besides this, I've known him personally for the past 15 years and can say he is brutaly honest about procedures and techniques he tries out, and if he finds they are impractical he can be relied upon to say as much publcly EVEN IF IT COSTS HIM MONEY. That's the kind of integrity we should all strive for, and is certainly an inspiration for me.

 

I am starting a list of doctors who oppose LLLT and the junk science it is founded upon. Here it is to date:

 

DOCTORS OPPOSED To LLLT:

Dr. Alan Feller- New York

Dr. William Lindsey-Virginia

Dr. Michael Behneer-New York

Dr. William Rassman-California

Dr. Raymond Konior-Illinois

 

I encourage all patients to ask their HT doctors where they stand.

Dr. Mohmand, perhaps you will recant LLLT and join the good guys above.

 

I will keep contacting other HT doctors to find out their positions and publish their names here.

[Dr. Mohammad Humayun Mohma]

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.

[PLEASE GROW PLEASE]

I love how these cowards send you stuff to post.

You must be their duck.

Thanks but no thanks.

You laser guys arent "bad guys" ,just dumb

 

I am a unpaid poster on htn. What ever I say about lasers is true

[Dr. Mohammad Humayun Mohma]

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.

[Dr. William Lindsey]

Dr. M

 

I thought I had placed this question yesterday but don't see it. So, would you tell me regarding that study you mention above:

 

Who is the author?

What institution do they come from?

What peer reviewed journal has it been submitted to or published in?

 

Thanks

Dr. Lindsey McLean VA

[ryanmiller1122]

I actually work for the clinic where most of these pictures were taken. I am the one responsible for taking them directly from the digital camera they were taken with, adding only a watermark for identification purposes, then resizing them and putting them on the web. I do not use lighting or changes of any sort. The pictures themselves are enough without any of the tricks so commonly used by hair specialists, accross all treatment providers, not just LLLT providers. The originals can be found on (Link removed by moderator - See Terms of Service)

Edited June 30, 2011 by TakingThePlunge

[Bill - Seemiller]

Ryan,

 

You were warned, now you're banned.

 

Bill