P-30   RAPID ONSET OF ACTION OF MINOXIDIL 5% TOPICAL SOLUTION IN A 4-MONTH GERMAN OBSERVATIONAL STUDY ON BOTH PATIENTS AND PHYSICIANS

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

In this post-marketing surveillance study, questionnaire data from 733 male users with androgenetic alopecia treating with minoxidil 5% were available for statistical analysis. The study population included 150 physicians who used the minoxidil 5% solution by themselves. This inclusion procedure was adopted as it was assumed that physicians who tested the solution on themselves would take a particularly critical view of the tolerability and efficacy of the minoxidil 5% solution. After a 4-month treatment period with twice daily application of 1 ml minoxidil 5% solution (Regaine®), the affected area had become smaller in 488 of 725 eligible users (67.3%), was unchanged in 231 users (31.9%) and had become larger in six users (0.8%). In the promotion of new hair growth, minoxidil 5% was very effective in 54 of 725 eligible users (7.5%), was effective in 399 users (55.0%), moderately effective in 227 users (31.3%) and ineffective in 45 users (6.2%). Hair density had improved in 74.2% of 721 eligible users, was unchanged in 24.3% of users and had worsened in 1.5% of users after treatment for 4 months. During the first month of treatment 93 users (13.9%) noticed efficacy of minoxidil 5% solution. The majority of users reported efficacy during the second month of treatment (350 users, equivalent to 52.3%) and 226 users (33.8%) experienced efficacy during the third month. No information was provided for 64 users. Adverse events were documented for 13 patients (1.8%). The total number of reported adverse events was 14 and dominated by skin-related events. In conclusion, it could be demonstrated that minoxidil 5% solution proved to be efficacious in this observational study with respect to reduction of the affected scalp area, promotion of new hair growth and improvement of hair density. The onset of action was fast, with 60% of users reporting efficacy after only 2 months of treatment with the minoxidil 5% solution. There were minor differences between physicians and patients in the overall results.