P-29   A ONE-YEAR OBSERVATIONAL STUDY WITH MINOXIDIL 5% SOLUTION IN GERMANY: RESULTS OF INDEPENDENT EFFICACY EVALUATION BY PHYSICIANS AND PATIENTS

J. Rundegren, K. Mulzer Pharmacia Corporation, Helsingborg, Sweden and Erlangen, Germany.

In this observational study, male patients with androgenetic alopecia applied twice daily 1 ml minoxidil 5% solution (Regaine 5%) to their hair loss region on the scalp for 12 months. A total of 984 patients were evaluated by physicians and 346 patients carried out their own evaluation. The evaluations by the treating dermatologists showed that the affected area had become smaller in 561 of 904 eligible users (62.0%), was unchanged in 317 users (35.1%) and had become larger in 26 users (2.9%). In the promotion of new hair growth, minoxidil 5% solution was very effective in 143 of 902 eligible cases (15.9%), effective in 431 cases (47.8%), moderately effective in 186 cases (20.6%) and ineffective in 142 cases (15.7%). Adverse events were documented in 38 patients (3.9%) and were dominated by dermatological events. None of the adverse events was classified as serious. Patients were asked to conduct a hair-washing test on commencement of therapy and at intervals of 3 months. Using a supplied sieve, they had to collect the hairs, which were rinsed from the head during washing and send these to a centre, where they were counted. The mean number of hairs lost during washing at the time of the screening examination was 69.7, compared with 33.8 at the time of the last count. The users self-assessed their satisfaction with their scalp hair by using a visual analogue scale, ranging from “0” (“extremely dissatisfied”) to “10” (“very satisfied”). The score for satisfaction with the scalp hair increased during the study from 2.9 points at the screening examination, to 4.4 points at the last one-year examination. Tolerability was assessed as very good by 26.4%, as good by 62.2% and as moderate by 11.0% of the patients. In a comparison between the treating physicians and the patients the physicians rated the efficacy of treatment expressed as good or very good at about 25% more often than the patients. In conclusion, the subjective evaluation of the physicians and the patients themselves as well as the objective evaluation of lost hairs clearly demonstrated the efficacy of minoxidil 5% under post-marketing conditions.