Evaluation of efficacy and safety profile of niosomal kopexil 1% lotion compared to niosomal minoxidil 2% lotion in malepattern alopecia

Conventional topical treatments for male-pattern alopecia (MPA) have limited penetration into hair follicles and unwanted side effects, resulting in low patient compliance. We aimed to evaluate the efficacy and safety of niosomal kopexil 1% lotion compared with niosomal minoxidil 2% lotion in patients with MPA. We conducted a prospective, double-blind, randomized clinical trial at Afzalipour Hospital of Kerman University of Medical Sciences, Kerman, Iran. Thirty participants with MPA were randomized to apply 1 ml of niosomal minoxidil 2% lotion or niosomal kopexil 1% lotion twice a day for 24 weeks. We assessed the efficacy of treatments as the percentage of change in hair density in monthly sessions compared to the baseline using a dermatoscope; we also assessed patient satisfaction and side effects. Thirty participants were enrolled, 29 of whom completed the study. The mean change in hair density was significantly higher with niosomal kopexil compared with niosomal minoxidil (23.2 ± 1.3 and 14.2 ± 0.2, respectively). The hair density increased by 57.6 ± 3.7% and 25.6 ± 4.2% in the kopexil and minoxidil groups, respectively (P < 0.001). Patients reported significantly greater satisfaction with niosomal kopexil than with niosomal minoxidil (P < 0.001). No side effects were reported in either group. Despite the lower concentration, niosomal kopexil revealed significantly higher efficacy of treatment and satisfaction of patients compared to niosomal minoxidil.