Rogaine Foam original paper

[lanthanos]

Page 1

 

[Bill - Seemiller]

Lanthanos,

 

I removed the other thread containing the other pages because it was conjesting this section of the forum. However, I saved the pages and attached the remaining ones below for everyone's review.

 

Best wishes,

 

Bill

 

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[Bill - Seemiller]

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[Bill - Seemiller]

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[Bill - Seemiller]

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[Bill - Seemiller]

Page 6

 

[Bill - Seemiller]

Page 7

 

[lanthanos]

Things to note from this paper.

 

1. New hairs plateau at 4 months. Is this because no new hairs are growing, or is it because the Rogaine is making some hairs in telogen fall out, thus causing a decrease in some hairs, but really it is a good decrease because it has cycled those telogen hairs into anagen? Why wasn't this study done longer than 4 months to determine which of these two is happening, like the liquid study which was done for 48 weeks?

 

2. The study author is Elise Olsen. olsen001@mc.duke.edu. I tried e-mailing her, no reply.

 

3. Subject assessment of hair loss condition while on placebo (combining slightly improved, moderately improved, and significantly improved) is 42.4% say their hair is improved!!!!

 

4. Compare the opinions of subject vs experts. Subjects on foam say: no change 17.8%, slightly improved 22.8%, moderately improved 26.1%, significantly improved 21.7%.

Expert independent panel review of photographs says: 52.2% no change, 30.6% minimal growth, 7.8% moderate growth, 0% great growth. The subjects had a much higher opinion of their results than the independent reviewers.

[mmhce]

I have not read through the entire document, but how much more effective is the foam in comparison to normal 5% or 15% minoxidil (in conjunction with azelaic acid)?

[lanthanos]

There is no study comparing foam to liquid.

 

The only mention is on page 2 of this paper. They talk about the "hamster ear model"...I don't anything about this, but seems obvious that it's an animal model in which to test hair loss drugs. They say the foam showed greater uptake at 1 and 2 hours but the reference is simply to an abstract that I can't find.

 

They also talk about the the stump-tailed macaque animal model of testing hair loss drugs. They used 6 monkeys. First they they treated them with water for 4 months, then waited 3 months, then treated them once daily with the liquid for 4 months, than waited 3 months, then treated them with the foam for 4 months. They found that there was a greater increase in hair weight from the foam. The reference for this is also an abstract that I can't find.

[lanthanos]

Ok I found the two references. They were abstracts in conference poster sessions.

 

Uptake of minoxidil from a new foam formulation devoid of propylene glycol to hamster ear

hair follicles

R Stehle,1 G Ewing,1 J Rundegren2 and B Kohut2 1 Pharmaceutical Sciences, Pfizer, Inc,

Kalamazoo, MI and 2 Consumer Healthcare, Pfizer, Inc, Morris Plains, NJ

Post-marketing studies show that the present topical minoxidil formulations are considered oily and

in some cases there are reports of skin irritation. A major cause of the apparent inferior cosmetic

properties and adverse effects of the current formulations on the skin is the rather high content of

propylene glycol. Thus a more cosmetically acceptable minoxidil foam formulation, devoid of propylene

glycol was developed. In order to test the availability of minoxidil to hair follicles hamster ears

were treated with minoxidil 5% foam in comparison to the current minoxidil 5% solution (Rogaine?®

Extra Strength), which served as a positive control. The foam was liquefied by gentle heating to 40C

and then 20 ??l was withdrawn with a positive displacement syringe and spread on the ventral ear

surfaces of a hamster, continuously and lightly anesthetized by controlled inhalation of isoflurane.

After 1 to 2 hours, the animal was sacrificed and the ears removed and carefully dissected to isolate

the sebaceous gland minoxidil content as an aqueous solution. Each sample was analyzed by HPLC

with electrochemical detection against minoxidil as an external standard. After one hour of minoxidil

treatment of the hamster ears the foam showed a sebaceous gland uptake of 5.9% of the total

minoxidil, while the positive control showed an uptake of 2.0% of the total minoxidil. After 2 hours

of treatment the uptake from the foam was 6.5% in one series of experiments and 4.1% in another

series of experiments, while the uptake from the positive control was 1.2% only. Thus the delivered

dose of minoxidil from the foam to the hamster ear sebaceous glands after one hour treatment was

about three times higher than for the minoxidil 5% solution. After two hours of treatment the minoxidil

delivery from the foam formulation increased to 3.4 to 5.4 higher than for the minoxidil 5% solution.

It is concluded that the new minoxidil 5% foam formulation is delivering minoxidil more

effectively to the sebaceous gland of the hamster ear than does the current minoxidil 5% solution.

[lanthanos]

The other abstract.

 

587

Hair growth efficacy assessment of a new topical minoxidil foam formulation in the stumptail

macaque

J Rundegren, AWestin and B Kohut Pfizer Consumer Healthcare, Morris Plains, NJ

The currently available topical minoxidil formulations for treating pattern hair loss contain a substantial

proportion of propylene glycol, which makes these formulations appear oily and in some

cases irritating to the patient's scalp skin. A more cosmetically accepted and user-friendly minoxidil

5% foam formulation devoid of propylene glycol was developed and tested for hair-growing efficacy.

A comparison was made to the hair-growing efficacy obtained for a topical minoxidil 5% solution

(positive control) in a cross-over design in six stumptail macaque monkeys. The animals were

housed in an AAALAC-accredited facility. Each formulation was applied to the balding scalp of the

animals by painting with a brush. A scalp target area of one square inch was located by permanent

tattooing in order to find the identical area repeatedly over the course of the study. The foam is thermo

labile and will melt in contact with the scalp skin. For the present study the foam was liquefied by

warming to body temperature before dosing. The dosing was 250 ??l once a day for four months and

there was a wash-out period of three months. The efficacy endpoint was weight of hairs cut from the

target area after every 4 weeks. The accumulated hair weight measure during the four months was

used for comparisons. Any adverse effects arising from use of the new formulations were also assessed.

The dosing accuracy of the 250 ??l dose was followed during a 17-day period by weighing the brush

before and after application and was found to be around 20% (CV%), which was considered an

acceptable accuracy. The minoxidil 5% foam resulted in a mean hair weight over the four months

of 12.40 mg compared to 9.27 mg for the positive control (p<0.031). The formulations did not produce

any adverse effects. Body weights were maintained and scalp skin inspections showed normal

appearance of the skin. It is concluded that the new minoxidil 5% foam formulation is at least as

effective as the current 5% minoxidil solution in the stumptail macaque.

[lanthanos]

In both studies they liquefy the foam before applying it. Kind of an important point, don't you guys think.