Efficacy of the association of topical minoxidil and topical finasteride compared to their use in monotherapy in men with androgenetic alopecia: A prospective, randomized, controlled, assessor blinded, 3-arm, pilot trial.

Abstract

Topical minoxidil (MNX) 2%-5% and oral finasteride (F) 1 mg/day are the only two pharmacological treatments authorized for androgenetic alopecia (AGA). Recently, a 2.2 mg/mL topical formulation of F was developed to minimize the systemic adverse effects associated with the oral formula. MNX and F act through different mechanisms; therefore, their association could improve clinical efficacy. To evaluate the efficacy of the association of 5% MNX and 0.25% topical F compared to their use in monotherapy, a 6-month, prospective, randomized, assessor-blinded trial was conducted. Forty-two males, mean age 24 ± 3 years, with AGA (I-VII of Norwood-Hamilton Grading Scale), treatment naive or free from any therapy for at least 6 months, were enrolled and randomly assigned to three arm treatment groups (2:1:1): group A (n = 19, the subjects applied 5% MNX in the morning and F spray in the evening), group B (n = 12, the subjects applied F spray in the evening), and group C (n = 11, the subjects applied 5% MNX twice daily). The efficacy of treatments was evaluated at baseline and after 3 and 6 months using a global photography score (GPAS; from -3 to +3) and trichoscopy evaluation and assessed by an investigator unaware of treatment allocation. At baseline and after treatments, the serum levels of follicle-stimulating hormone (FSH), luteinizing hormone (LH), dehydroepiandrosterone sulfate (DHEA-S), and testosterone were also evaluated. All treatments resulted in an increase in hair density compared to baseline. However, this improvement was significant only for group A (MNX + F), both at three (+56 density/cm2 , p < 0.05) and six (+81 density/cm2 , p < 0.001) months. The mean change from baseline in hair density was higher for group A compared to other groups and statistically different compared to group B (F) (p < 0.01), both after 3 and 6 months. Group A showed a global photographic assessment score (GPAS) significantly higher compared to group B (p < 0.001) and group C (p < 0.05) both at 3 and 6 months (2.0 ± 0.7 vs. 0.6 ± 0.8 and 1.3 ± 0.6; respectively). A significantly greater percentage of subjects in Group A achieved a GPAS score of ≥2 in comparison with Groups B and C both after 3 and 6 months (79% vs. 8% and 41%, respectively). No significant differences were observed in mean hair diameter and hormonal levels between the three groups. Good tolerability was observed in all treated groups. The association of 5% MNX lotion and 0.25% F in spray formulation in patients with AGA showed a significantly higher clinical and instrumental efficacy compared to the monotherapies, with comparable tolerability and safety profile.