Comparative Clinical Study Evaluating the Efficacy and Safety of Topical 5% Cetosomal Minoxidil and Topical 5% Alcohol-Based Minoxidil Solutions for the Treatment of Androgenetic Alopecia in Indian Men.

Abstract

Introduction Patients with androgenetic alopecia (AGA), who use alcohol-based topical minoxidil solutions, frequently experience localized irritation, dryness, and scalp redness. In this study, we compared the safety and effectiveness of topical 5% cetosomal minoxidil solution to those of topical 5% alcohol-based minoxidil solutionin Indian men with AGA. Methods In this randomized, open-label study, male patients with AGA were randomized 1:1 to receive either solutions twice daily for 16 weeks. Efficacy endpoints included changes in basic and specific (BASP) grading, improvement in the trichoscopy score, and global photography at week 16 from baseline, whereas safety was evaluated by adverse events reported by patients and hair-related quality of life (QoL) using the Hairdex-29 questionnaire. Results Of the 80 patients, only 40 completed the study and were considered for complete analysis. Twelve out of 23 patients (52%) in the cetosomal minoxidil group and four out of 17 patients (24%) in the alcohol-based minoxidil group showed a positive increase in hair growth according to the trichoscopy score (p=0.1). According to the BASP grading system, nine patients (39%) and five patients (29%) in the cetosomal and alcohol-based minoxidil groups, respectively, showed improvement (p=0.73). Similarly, 19 (83%) and 10 (59%) patients in the cetosomal and alcohol-based minoxidil groups, respectively, reported positive hair growth on the global photography assessment (p=0.15). All the patients tolerated the treatment well, with no discontinuation in either group. There were four adverse events in the cetosomal minoxidil group, reported by two (9%) patients, whereas in the alcohol-based minoxidil group, 10 adverse events were reported by seven (41%) patients (p=0.02). In addition, the mean Hairdex-29 score of 40.26±4.71 at baseline improved to 32.32±3.35 in the cetosomal group, whereas it improved to 34.64±3.41 from 39.64±4.98 in the other group (p=0.03). Conclusions The 5% cetosomal minoxidil group showed improved safety but similar efficacy when administered twice daily. Therefore, cetosomal minoxidil may be a better option for treating AGA in males who are sensitive or nontolerant to alcoholic formulations.