Androgenetic alopecia (AA) is characterized by progressive miniaturization of scalp follicles mediated by dihydrotestosterone. Conventional treatments include oral finasteride (a type II 5α-reductase inhibitor) and topical minoxidil, but topical regimens… Click to show full abstract
Androgenetic alopecia (AA) is characterized by progressive miniaturization of scalp follicles mediated by dihydrotestosterone. Conventional treatments include oral finasteride (a type II 5α-reductase inhibitor) and topical minoxidil, but topical regimens can be limited by application burden and local irritation. Low-dose oral minoxidil (2.5 mg) augments follicular blood flow and anagen prolongation, yet evidence on combining it with oral finasteride (1 mg) over the long term remains sparse. A once-daily coformulation may promote convenience and adherence. The aim of this study was to evaluate the 12-month effectiveness of a daily oral minoxidil–finasteride regimen in adult men with AA, focusing on (i) hair density changes across Norwood severities, (ii) effect sizes for different baseline categories, and (iii) inter-rater reliability of visual hair-loss scoring. A retrospective cohort of 502 men (age ≥ 18 years, Norwood 2–7) was identified from a digital health service’s records (January 2020 to December 2023). All received finasteride 1 mg per day plus minoxidil 2.5 mg per day. Standardized scalp images at baseline and 12 months were graded using a seven-point scale (from −3 = significant loss; to 0 = stable and no loss; to +3 = significant growth). The primary endpoint (mean seven-point change) was compared with zero using a one-sample t-test. Effect sizes (Cohen’s d, Hedge’s g) were calculated, and inter-rater reliability (Cohen’s κ) was assessed for baseline Norwood classifications and seven-point scores. Statistical clinical significance was set at P < 0.05. Among 502 men (mean age 35.5 years, SD 12.1), 92.4% (464 of 502) were stable or improved at 12 months, with 57.4% (288 of 502) showing overt regrowth. The inverse-variance weighted mean seven-point change was 0.58 (95% confidence interval 0.51–0.65, P < 0.001), indicating a statistically significant overall increase in hair density. Norwood 2–3 demonstrated moderate effect sizes (d ≈ 0.27–0.74), while Norwood 5–6 ranged from d ≈ 0.88 to d ≈ 1.11 (P < 0.001). Despite smaller sample sizes in Norwood 6 and 7, both groups recorded 100% stable or improved outcomes, with half to two-thirds demonstrating hair regrowth. Inter-rater reliability for baseline Norwood staging was κ = 0.33 (fair agreement), and seven-point changes κ = 0.20 (slight agreement), reflecting subjective variability in photo-based assessments. Daily administration of low-dose oral minoxidil and finasteride yielded robust, statistically significant improvements in men with AA (> 92.4%), including advanced stages. Effect sizes ranged from moderate in early hair loss to large in severe categories, suggesting a broad therapeutic window. Nonetheless, modest κ-values reinforce the necessity for objective imaging protocols or artificial intelligence-driven methods in future research. Prospective, controlled trials incorporating explicit safety monitoring and patient-reported outcomes are warranted to optimize dosing and validate long-term tolerability.
               
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