Merck’s Propecia FDA Trial Results
On Sunday, March 23, 1997, Merck released their phase III FDA trial results for its new hair loss drug, Propecia at the annual American Academy of Dermatology meeting. The study studied over 1,500 men of varying ages and amounts of hair loss. Results were submitted to the FDA in December 1996 for approval. Approval is expected between the end of 1997 and spring of 1998. Propecia is a 1mg form of Merck’s prostate drug, Proscar (Finasteride), which has been available by prescription for several years now. Proscar works by inhibiting the conversion of Testosterone to Dihydrotestosterone (DHT). DHT is the primary male hormone which triggers male pattern hair loss in men.
How Results Were Assessed
- 1. Scalp hair counts in a 1-inch diameter circle.
- 2. Patients self assessment by means of a questionnaire.
- 3. The clinical assessment by the doctors themselves observing changes in scalp hair.
- 4. Pre and post treatment photos evaluated by an expert panel of dermatologists in a blinded fashion.
There were 2 12 month, double-blind placebo controlled studies conducted in the USA and another outside the US.
Patient Characteristics
1,553 men 18-41 years old Norwood Classification II, III, IV, or V Shedding and/or recent hair loss . 1mg Propecia or Placebo given daily.
Patient Results
| Study | Time of Evaluation | Result | Dose | |
| Usa | 6 months | +70 hairs per inch | 1 mg Propecia | |
| Usa | 6 months | -15 hairs per inch | Placebo | |
| International | 6 months | +60 hairs per inch | 1 mg Propecia | |
| International | 6 months | -22 hairs per inch | Placebo | |
| Usa | 12 months | +90 hairs per inch | 1 mg Propecia | |
| Usa | 12 months | -21 hairs per inch | Placebo | |
| International | 12 months | +80 hairs per inch | 1 mg Propecia | |
| International | 12 months | -22 hairs per inch | Placebo | |
Patient Self Assessment
| Question | Yes | Yes |
| Propecia | Placebo | |
| Do you see your vertex baldspot getting smaller? | 42 % | 21% |
| Has your hair appearance improved? | 58 % | 35 % |
| Has your hair growth increased? | 56 % | 33 % |
| Was the treatment effective in slowing down your hair loss? | 68 % | 45 % |
| Satisfied with the appearance of their frontal hair | 29 % | 17 % |
| Satisfaction with the hair on the top of the head | 36 % | 20 % |
| Satisfaction with appearance of their hair overall | 39 % | 22 % |
Other Assessment
| Group | Increse | Increase |
| Propecia | Placebo | |
| Clinical Investigators | 65 % | 37 % |
| Photographic Expert Panel | 48 % | 7 % |
Safety / Side Effects
| Effect Propecia | Placebo | Actual (Propecia - Placebo) |
| Withdrew due to any side effect | 1.7 % | 2.1 % 0.4 % |
| Decreased Libido | 1.8 % | 1.3 % 0.5% |
| Difficulty with Erection | 1.3 % | 0.7 % 0.6 % |
| Decrease in amount of semen | 0.8 % | 0.4% 0.4 % |
Men who discontinued Finasteride had no further side effects. Side effects disappeared in most who continued the study despite side effects. No birth defects were experienced with any of the several patients who impregnated someone while using Finasteride.