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Low-dose oral minoxidil (Rogaine) was well-tolerated and had similar efficacy to topical minoxidil for treatment of male androgenetic alopecia, providing another option for patients intolerant to topical treatments, a randomized trial from Brazil showed.

Among 68 participants, the mean change from baseline to week 24 for the frontal area between groups was 3.1 hairs per cm² (95% CI -18.2 to 21.5, P=0.27) for terminal hair density and 2.6 hairs per cm² (95% CI -10.3 to 15.8, P=0.32) for total hair density, reported Paulo Müller Ramos, MD, PhD, of São Paulo State University, and co-authors.

For the vertex area, the mean change from baseline to week 24 was 23.4 hairs per cm² (95% CI -0.3 to 43.0, P=0.09) for terminal density and 5.5 hairs per cm² (95% CI -12.5 to 23.5, P=0.32) for total hair density, they wrote in .

The percentage increase in terminal hair density was 27.1% higher for the oral minoxidil group (P=0.005) in the vertex and 13.1% higher (P=0.15) in the frontal scalp.

Sixty percent of the oral minoxidil group and 48% of the topical minoxidil group had clinical improvement in the frontal area, with no significant difference between the groups (P=0.24), according to consensus of three dermatologists blinded to treatment. More patients in the oral minoxidil group had clinical improvement in the vertex area than patients in the topical minoxidil group (70% vs 46%, P=0.04).

Oral finasteride (Propecia) and topical minoxidil are the only two FDA-approved medications for androgenetic alopecia, a condition known to negatively affect self-esteem and quality of life. With their respective adverse effects on sexual function and hair and scalp health, there is growing interest in low-dose oral minoxidil (0.25 to 5 mg daily) as an alternative therapy, the authors noted.

"We have observed that both oral and topical minoxidil formulations are effective and generally well-tolerated by our patients," Shoshana Marmon, MD, PhD, of New York Medical College in Valhalla, told MedPage Today. "Moreover, minoxidil appeals to patients who are hesitant to use finasteride due to the risk of adverse sexual effects."

For the single-center study conducted in Brazil from January to December 2021, 90 participants with mild to moderate androgenetic alopecia were randomized 1:1 to receive oral minoxidil 5 mg daily plus a topical placebo solution or 1 mL of topical minoxidil 5% twice daily and oral placebo for 24 weeks. Of these patients, 68 completed the study. Mean age was 36.6, and both groups were similar in terms of demographics and severity of the condition.

Hypertrichosis was the most common adverse effect, reported by 49% of the oral group and 25% of the topical group. There were no significant changes in heart rate and blood pressure.

Dropout rates were similar between the oral and topical groups, at 27% and 22%, respectively, including 2% and 7% due to adverse effects. Most were related to the interrupted attendance due to the COVID-19 pandemic, except for individual side effects of insomnia, persistent scalp eczema, and intense hair shedding in the topical group.

Transient hair loss -- reported to occur in the first 2 months of treatment due to the early release of hairs in the telogen phase (premature teloptosis) -- affected 9% of the oral minoxidil group and 16% of the topical minoxidil group. "It is crucial to inform patients about its transient and self-limited nature to prevent early treatment interruption," Ramos and team noted.

Marmon said that despite the limitations acknowledged by the authors, such as a small sample size and a relatively high rate of patients lost to follow-up, "the study's findings are valuable for clinicians."

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