S11 TOPICAL MINOXIDIL SOLUTION 5% IN THE TREATMENT OF ANDROGENETIC ALOPECIA IN MALES

Wolff H. Dept. of Dermatology, Ludwig-Maximilians-University, Munich, Germany.

It has been over a decade since topical minoxidil was first approved for the treatment of androgenetic alopecia or hereditary hair loss in the USA. Since then, the clinical experience with the use of minoxidil in a variety of alopecias is vast. This report will present the results of clinical trials on 5% topical minoxidil solution (5% TMS, Rogaine Extra Strength for Men, Regaine 5%) with special focus on the definitive 48 week FDA approved trial. The first study was a methodology trial for 48 weeks in 64 patients. The second trial was a 32 week multicenter study in 345 patients and the definitive trial was a 48 week multicenter study carried out in 393 patients. Study medication was 1 ml solution applied twice a day. The primary endpoints were: 1) change in non-vellus hair counts from baseline, 2) the patient’s assessment of change in scalp coverage, 3) the patient’s assessment of whether treatment was beneficial. A visual analogue scale was used for the two latter endpoints. Safety was extensively monitored and included laboratory parameters, electrocardiogram, serum minoxidil levels, local tolerance and medical events. The results of the definitive trial showed that 5% TMS was statistically significantly more effective than 2% TMS for all three endpoins. The trial also showed that the same number of non-vellus hairs was obtained with 5% TMS at 8 weeks as with 2% TMS at 16 weeks. The safety analysis showed no clinically important adverse effects of 5% TMS. There were more dermatological events with 5% TMS than with 2% TMS, primarily scalp irritation. A concerted evaluation of the two multicenter studies showed that 20-45% more hair regrowth was obtained with 5% TMS than with 2% TMS over time.