Efficacy and safety of a new 10% topical minoxidil versus 5% topical minoxidil and placebo in the treatment of male androgenetic alopecia: a trichoscopic evaluation.

INTRODUCTION

Androgenetic alopecia is a stressful condition for males. Minoxidil 2% and 5% have been FDA approved for treatment of this condition. In literature, all studies have compared minoxidil 5% with 2%. Although other concentrations (2% to 12.5%) are available nowadays, we believe our study is the first to compare 10% versus 5% topical minoxidil in treatment of AGA.

OBJECTIVE

To compare the efficacy and safety of 5% topical minoxidil with 10% topical minoxidil and placebo in AGA treatment.

MATERIALS AND METHODS

36-weeks, double-blinded, placebo-controlled, randomized trial. A total of 90 men with AGA. First group have applied 5% minoxidil solution, second group applied 10% minoxidil solution; or third placebo group. Efficacy was evaluated clinically and trichoscopically.

RESULTS

After 36 weeks of therapy; 5% topical minoxidil (0.47 ± 0.26) (0.59 ± 0.64) was significantly superior to 10% topical minoxidil (0.05 ± 0.13) (0.45 ± 0.74) and placebo (0.01 ± 0.05) (-0.03 ± 0.08) in terms of change from baseline in total vertex and frontal hair mean count respectively. Pull test change to negative in minoxidil 5%: (37%) patients after 6 month treatment, Minoxidil 10% group (37.5%) patients changed and in placebo group all patients after 6 month were the same (0%) change. No reported sexual dysfunction in all three groups.

CONCLUSION

Five percent of topical minoxidil was moderately superior to 10% topical minoxidil and placebo in increasing hair regrowth opposite to the expected, the irritation was marked for 10% topical minoxidil. Psychosocial stress after 10% usage were worsen by the shedding, irritation compared to their high expectation in comparison to 5% usage.