Oral Minoxidil in the Management of Androgenetic Alopecia

Abstract

Androgenetic alopecia (AGA) is one of the most common types of hair loss. It is estimated that 85% of men and 40% of women experience it at some point in their lifetime. Other therapies approved by the Food and Drug
Administration for hair loss treatment are minoxidil (topically) and finasteride (orally). However, adherence to topical therapy with minoxidil is poor; however, with the use of finasteride, there is a potential for sexual side effects. There is an unapproved treatment called low-dose oral minoxidil (LDOM), which has shown promise in the treatment of AGA. An established literature search was performed through PubMed/MEDLINE, Embase, Cochrane Library and Scopus for the period from inception of each database through March 2026. All studies of LDOM in patients with AGA that were either randomized controlled trials (RCTs), prospective cohort studies, retrospective analyses or meta-analyses were included. The three primary outcome variables utilized in this review included: Change in hair density, terminal hair count and global photographic improvement.
Other outcome variables collected from the studies included: Adverse event profiles, adherence and patient- reported outcomes. The quality of studies was evaluated utilizing the Cochrane Risk of Bias assessment tool
for RCTs. Four RCTs in patients with AGA demonstrated no statistically significant difference in hair density (pooled standard mean difference [SMD] 0.02; 95% confidence interval [CI] −0.25–0.29; P = 0.88; I2 = 0%)
or hair diameter (SMD −0.25; P = 0.34) for oral and topical minoxidil. One double-blinded RCT performed photographic analyses that demonstrated superior results at the vertex for oral minoxidil (P = 0.04). There were
also significantly more cases of hypertrichosis (risk ratio 2.01; 95% CI 1.18–3.41; P = 0.01) in patients receiving oral minoxidil. In a multi-center safety study that included 1404 patients, there were no life-threatening adverse
events reported at doses of 0.25–5 mg/day. Clinical response rates of 70–100% have been reported in cohort studies. At doses of 0.25–5 mg/day, LDOM demonstrates comparable efficacy to topical minoxidil for the
treatment of both male AGA and female pattern hair loss and a manageable and dose-dependent adverse effect profile. Advantages of LDOM therapy include: Improved adherence, ease of administration, lower cost and use in patients who cannot tolerate topical therapy. The most clinically relevant adverse effect for LDOM therapy continues to be hypertrichosis, especially in women. LDOM should be considered a viable therapeutic option in patients who do not respond to or adhere to topical therapies. Larger, longer-duration standard RCTs are required to establish the recommendations for dosing and evaluate the long-term cardiovascular safety of LDOM