Long-term effectiveness and safety of topical finasteride 0.25% monotherapy in male androgenetic alopecia: a 52-week real-world retrospective study
Giuseppe Gallo, Luca Mastorino, Pietro Quaglino, Simone RiberoAbstract
Background
Oral finasteride is a cornerstone in the treatment of male androgenetic alopecia (AGA), yet concerns regarding systemic adverse events often limit patient adherence. Topical finasteride 0.25% has emerged as a promising alternative to minimize systemic exposure while maintaining local efficacy.
Objectives
To evaluate the effectiveness and safety of topical finasteride 0.25% as monotherapy in male patients with AGA over 52 weeks in a real-world setting.
Methods
A retrospective observational study was conducted at the Dermatology Unit of the University of Turin. Medical records of male patients treated with topical finasteride 0.25% monotherapy between April 2022 and November 2025 were reviewed. 123 adult men with AGA were included. Patients were evaluated at baseline (T0) and after 52 weeks (T52) using standardized clinical photography and videodermoscopy (VIDIX system), with paired intra-patient comparisons. Efficacy was assessed via trichoscopic changes in Total Hair Number (THN). Secondary outcomes included hair shaft thickness (HST), terminal-to-vellus hair ratio, Physician Global Assessment (PGA), patient-reported outcomes, and safety.
Results
A total of 123 male patients (mean age 32.4 ± 8.1 years) were included. At 52 weeks, significant increases in THN were observed in both the vertex (+21.8 hairs/cm2; P < 0.001) and temporal regions (+29.4 hairs/cm2; P < 0.001). Significant improvements were also noted in HST and the terminal-to-vellus ratio. The treatment was well tolerated; 7.3% of patients reported mild, transient local irritation. No systemic adverse events related to sexual function or mood were reported.
Conclusions
Topical finasteride 0.25% monotherapy demonstrates sustained clinical efficacy and a favorable safety profile after one year of treatment. These findings support its use as a viable therapeutic option for male AGA, particularly for patients reluctant to undergo systemic therapy.