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abstractpubmed· abstract· item 41742379

BACKGROUND: Antiandrogen therapy is a cornerstone in managing female pattern hair loss (FPHL), yet comparative efficacy data between commonly used agents such as spironolactone and bicalutamide are limited. OBJECTIVES: To compare the efficacy and safety of bicalutamide (50 mg day-1) vs. spironolactone (100 mg day-1) monotherapy in women with FPHL. METHODS: This randomized, double-blind, parallel-group clinical trial was conducted at a tertiary care centre in India between February 2024 and March 2025. In total, 204 women aged 18-50 years with Sinclair grade II-V FPHL were randomized. Participants received either spironolactone 100 mg day-1 or bicalutamide 50 mg day-1 orally for 24 weeks. Trichoscopic assessments were performed at baseline and 24 weeks. Primary outcomes were changes in hair density and shaft diameter at two fixed scalp points [12 cm (frontal) and 24 cm (vertex) from the glabella]. Secondary outcomes included global photographic assessment, reduction in Sinclair hair shedding score and safety profile. The trial was registered with the Clinical Trials Registry of India (CTRI/2024/01/062101). RESULTS: Of 204 randomized participants, 188 (92.2%) completed the trial. The mean (SD) increase in hair count at the frontal site was 5.05 (3.61) hairs cm-2 in the bicalutamide group vs. 3.13 (2.62) hairs cm-2 in the spironolactone group [mean difference 1.92; 95% confidence interval (CI) 1.01-2.62; P < 0.001]. At the vertex site, the increase was 6.32 (9.38) vs. 3.06 (10.76) hairs cm-2, respectively (mean difference 3.26; 95% CI 0.35-6.08; P = 0.028). Hair shaft diameter increased more with bicalutamide at both sites [mean difference 2.87 μm; 95% CI 2.12-3.32 (frontal) and 2.10-3.36 μm (vertex); P < 0.001 for both]. Adverse events were reported in 18.6% of spironolactone-treated and 11.7% of bicalutamide-treated participants. CONCLUSIONS: Bicalutamide produced greater trichoscopic improvements than spironolactone; however, no significant between-group differences were observed in clinical endpoints. Limitations include a short follow-up period, single-centre design and per-protocol analysis, which may limit generalizability.