Propecia 2 Year Frontal Study Results
What happened?
This is it. Although the rest of the conference will have some useful information, everything besides this meeting is mostly academic. This meeting provided the most detailed, new About Propecia, Rogaine Extra Strength/Minoxidil 5%, and new treatments. Doctors involved with both Merck's and Upjohn's studies presented information, as well as Vera Price, possibly the world's foremost researcher and authority on Minoxidil.
Dr. Vera Price began the meeting with her talk, "Hair Cycles, hormones, and the neural crest." Dr. Price began by comparing similarities of alopecia areata and androgenetic alopecia and the differences between hair on the top of the head from that of the side and back of the head. She asked the question, "Are there two types of hair follicle?"
Dr. Price reported that the 'alopecia universalis' reported in the recent 'hairless' gene discovery by Dr. Angela Christiano in hairless pakistanis is a non-inflammatory, genetic form of hair loss, not the alopecia areata related form. This loss is totally unrelated and not directly applicable to alopecia areata or androgenetic alopecia. Dr. Price recommended naming this hairlessness 'generalized atrichia.'
Dr. Price then returned to the question of whether there are two follicles. From avian embryology, the two types of follicles come from diffeent parts (mesoderm - sides/rear, top - neural crest). Recent studies showing different levels of 5-alpha, aromatase, and ARs in hair follicles in women & men with AA (Sawaya Price, JID 109:296-30, 1997) support the idea that there may be two different follicles. Dr. Price pointed out that the waddled starling is an avian model of androgenetic alopecia. It loses feathers on frontal scalp during breeding time when androgen levels rise.
Dr. Ronald J. Trancik, PhD, senior director of clinical research at Pharmacia & Upjohn, presented data from several 5% Minoxidil Topical
Solution studies. Minoxidil concentrations in the blood were shown to peak at 4-8 hours for Minoxidil 2% and at 4-12 hours for Minoxidil 5%. In a 120 week study of 5% Minoxidil, continued growth was shown at the end of the study. In two other studies using hair count and photographic assessment, the following results were shown:
| Drug | Moderate/dense | Minimal | No change | Loss hair | Unable to determine |
| 5% Minoxidil | 30 % | 24 % | 29 % | 6 % | 11 % |
| 2% Minoxidil | 15 % | 23 % | 47 % | 1 % | 13 % |
| Placebo | 7 % | 22 % | 61 % | N/A | N/A |
| Drug | Moderate/dense | Minimal | No change | Loss hair | Unable to determine |
| 5% Minoxidil | 40 % | 22 % | 32 % | 5 % | 1 % |
| 2% Minoxidil | 22 % | 21 % | 50 % | 5 % | 1 % |
| Placebo | 7 % | 10 % | 61 % | 14 % | 8 % |
See the abstract
Keith Kaufman of Merck, senior director of clinical research in endocrinology and metabolism, presented 2 year study data on Propecia. Some of the information from the earlier meeting was duplicated. Please click here to see the data presented earlier the same day. Dr. Kaufman did confirm that type II 5-alpha reductase has been shown to be localized in hair follicles, and that Propecia does reduce DHT in the follicle itself as well as in general circulation. In the two year vertex studies, 17% of men lost hair at 24 months compared with 83% who gained or kept hair. Of the 17% of men who lost hair, only 1% showed a visible decrease in hair. Photos were presented of several trial participants showing patients classified as 3V and IV who had changed to type I-II after 2 years. Other classifications were shown with significant improvement. Dr. Kaufman showed slides detailing two year frontal (mid-anterior scalp,an area about 1 inch behind a normal hairline) results, including photographs of patients. Hair counts were shown to improve from around 10-11 additional haris per centimeter after one year to around 11-12 hairs per centimeter after two years, so results were maintained with slight improvement. Patients on placebo showed a sharp decrease in hairs in the first year. I am awaiting confirmation of exact numbers (a line graph was presented), but the decrease after one year was about 5 hairs per centimeter. After the first year, patients were placed on Propecia and showed an overall 8 hair increase per centimeter by the end of the second year, for a total of 3 hairs above baseline. The following table shows improvements judged by photographic analysis:
| Drug | Moderate Improvement | Slight Improvement | No visible Hair Loss | Slight Decrease |
| Propecia - 1 Year | 4 % | 34 % | 62 % | 1 % |
| Placebo - 1 Year | 0 % | 7 % | 85 % | 7 % |
| Propecia - 2 Year | 4 % | 38 % | 53 % | 5 % |
No patients in either group re rated as greatly improved.
Side effects were shown to reverse in 58% of men who continued treatment and stop in 100% of men who stopped treatment. In regards to the possibility of a man on finasteride impregnating a woman, Dr. Kaufman said, "We did extensive studies both in the 5 and 1mg dose measuring repeated semen analyses and there were no effects on any parameters..."
Some patients did improve from a slight result after one year to moderate results after two years, and from moderate to great. Some improvements in results between years one and two may be accounted for because of improvement of hair quality and length of initially grown hairs throughout the second year as hairs cycle and regrow. Hormone levels tested showed a 64% decrease of DHT in the scalp itself and a decrease of cirulating DHT of 68%. Testosterone increased 13% and estradiol increased 14%. Prolactine was unaffected. Prostate volume decreased 2.6% and Prostate Specific Antigen (PSA) decreased .2 ng/mL. No effect was seen on semen production or spermatogenesis.
Information on 5% Minoxidil was presented regarding several studies. Studies tested hair counts in a 2 centimeter square tatooed area using macrophotography. One study showed an increase in nonvellus hair count after 32 weeks of 40% on 5% Minoxidil, 30% on 2% Minoxidil and 5% on placebo. Another study showed a 60% hair count increase on 5% Minoxidil after 20 weeks and 25-30% on 2% Minoxidil. Unfortunately results level off over time and after about 110 weeks results between the two Minoxidils are similar with about a 25% increased hair count from baseline for Minoxidil 5% and around 20% for 2% Minoxidil. The topic of safety was discussed as well and the following information was presented. Only about 1.7% of a topical dose of Minoxidil is absorbed. In order for Minoxidil to affect blood pressure, a blood level of 20 ng/mL must be achieved. Serum minoxidil levels in long term clinical trials showed an absorption of 0.6 ng/mL for 2% Minoxidil and 1.2 ng/mL for 5% Minoxidil, so both are far below the threshhold for systemic blood pressure effects.