Background and Aim: Androgenetic alopecia (AGA) is the most common type of alopecia in men. Currently, minoxidil is the only topical drug which has been approved by FDA for the treatment of AGA. However, its efficacy is restricted because of its low skin penetration. Since vesicular systems such as liposomes and niosomes have higher efficacy and lower adverse effects, this study was conducted to compare the efficacy of topical niosomal minoxidil with conventional minoxidil in the treatment of AGA. Methods: This study was a randomized, controlled double-blind clinical trial. Ninety male patients with AGA according to Hamilton criteria were enrolled into this trial. The participants applied the interversion to which they were allocated twice a day, and were evaluated monthly for 6 months by a physician and patients self-assessments. Results: Eighty-eight patients completed the trial. Mean increased hair count in niosomal minoxidil group and conventional minoxidil group in the last visit were 28.18±11.00 and 14.22±5.23, respectively (P<0.001). Moreover, evaluation of treatment response according to the patients self-assessments were 8.72±5.03 and 3.33±2.67 in niosomal and conventional minoxidil, respectively, which revealed more satisfaction in niosomal group (P=0.001). With the exception of two cases in niosomal minoxidil group whom were withdraw due to scalp itching and erthema no other adverse effect was observed in either group. Conclusion: In the present study, application of topical niosomal minoxidil revealed an increase in the hair count in comparison with conventional minoxidil solution. Application of this new formulation for the treatment of AGA may be recommended.

Keywords: androgenetic alopecia, minoxidil, niosomal

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