Updates on the two FDA approved treatments for hair loss were announced at this weeks American Academy of Dermatology (AAD) meeting in San Francisco, CA.
First to report was Dr. Ron Trancik of Phamacia & Upjohn, who announced that 5% Minoxidil is still being studied for review by the FDA for approval in women. Two studies in women have been conducted which showed “strong trends” favoring 5% in women, but they have not shown enough statistical significance yet to gain final FDA approval for 5% Minoxidil in women.
Dr. Keith Kaufman of Merck presented updates on Propecia (Finasteride) based on the third and fourth years of their open study. Propecia is now in its fifth year of long term study and the final results will be announced and published next year, possibly at next years AAD meeting. The results presented were not the complete results and only compare individuals who have been on Propecia or placebo for the entire length of the trials. The patients who were switched after the first year to placebo (5%) from Propecia or to Propecia (45%) from placebo were not included in these results.
Although exact statistics were not given since the study is not yet final, graphs and other information presented showed several interesting aspects of the results. Overall haircounts in the Propecia group showed a small decline over years three and four, but overall most of the haircount improvement was maintained. This was offset by the results in the placebo group, who continued to worsen. The margin between hair counts of Propecia vs. non-Propecia users widened slightly as the placebo group continued to lose hair over the four years. Dr. Kaufman believes the decrease in hair count in the Propecia group is most likely due to synchronized hair shedding, since more of the hairs tend to grow and fall out at the same time when on an effective treatment for hairloss. Dr. Kaufman stated that these results are not yet complete and that full results will be released after the 5 year trial has completed and the final results have been assessed.
In the investigator’s photographic assessment, 71% of placebo users were rated as worsened after 4 years compared to 8% on Propecia. Investigators felt there was no change in 36% of Propecia users after 4 years compared to 29% of the placebo group, and overall 55% of the Propecia group was rated improved after years compared to 0% of the placebo group.
In patient self-assessment, 62% of Propecia patients felt Propecia was decreasing the size of their bald spot compared to 18% of placebo users, 78% of Propecia users thought it was improving the appearance of their hair compared to 39% of placebo users, 78% of Propecia users thought it was improving the growth rate of their hair compared to 36% of placebo users, and 90% of Propecia users felt it was slowing their hairloss compared to 64% of placebo users.
There were no reports of any serious adverse reactions to Propecia after 4 years, and reports of the initial side effects have stayed the same or decreased. In addition, Dr. Kaufman mentioned that men with natural type 2 5-alpha reductase (the enzyme Propecia blocks) deficiency have now been studied for over 25 years and the deficiency of type 2 5-alpha reductase does not appear to cause any long term health problems in men.
In followups to the earlier announced hair weight studies, results of the full 96 week studies on hair weight have shown a 36% net improvement in hair weight over placebo over 96 weeks. The study indicates that the percentage of hairs in the anagen (active growth) phase increases even more than the increase in hair count. This indicates that existing more existing hairs are entering the growth phase and that their density and quality is improving.
Overall, more than 3,800 men have been studied by Merck over 6 years on Propecia and there are over 1,000,000 users worldwide.