Low‐Dose Oral Versus Topical Minoxidil in Androgenetic Alopecia: A Randomized, Double‐Blind, Double‐Dummy Controlled Trial

ABSTRACT Background Androgenetic alopecia (AGA) is a prevalent, progressive condition with significant psychosocial impact. Current pharmacological modalities like topical minoxidil and finasteride have limitations. Low‐dose oral minoxidil has surfaced as a valid off‐label solution, with the practical advantage of once‐daily dosing. Objective To evaluate the efficacy and safety of topical and oral minoxidil in AGA. Methods In this double‐blind, double‐dummy randomized controlled trial, 100 patients aged 18–50 years with AGA were randomized to receive either twice‐daily topical minoxidil (5% in males, 2% in females) plus a placebo tablet, or once‐daily oral minoxidil (2.5 mg in males, 1.25 mg in females) plus a placebo spray for 6 months. The primary outcome was the proportion of patients achieving ≥ +1 improvement in a validated 7‐point global photographic scale. Secondary outcomes included patient satisfaction and adverse effects. Data were analyzed using SPSS v26 with p ≤ 0.05 as significant. Results Ninety patients completed 24 weeks of follow‐up. Photographic assessment demonstrated that mild‐to‐excellent improvement (≥ +1) occurred in both the oral (67%) and topical minoxidil (73%) groups ( p = 0.652). Patient‐reported satisfaction was high in both groups (topical: 70.5%; oral: 80.4%, p = 0.332), with a non‐significant trend favoring oral minoxidil at the moderate satisfaction threshold (58.7% vs. 38.6%, p = 0.057). Median improvement scores were comparable between groups for both clinician assessment and patient‐reported outcomes. Hypertrichosis was significantly more frequent with oral minoxidil (30% vs. 9%, p = 0.011), whereas contact dermatitis was exclusive to topical minoxidil (11% vs. 0%, p = 0.025). No serious adverse events were observed. Conclusion Both topical and low‐dose oral minoxidil demonstrated clinically meaningful improvement in androgenetic alopecia. Despite oral therapy exhibiting a trend toward higher patient satisfaction, this study was not powered to establish non‐inferiority or equivalence. The dermatologist‐assessed outcomes indicated no significant intergroup differences. Low‐dose oral minoxidil may be considered a practical alternative in selected patients, particularly where adherence to topical therapy is limited. Trial Registration ClinicalTrials.gov : NCT07273799