Topical Minoxidil is the only FDA–approved drug for treatment of female-pattern hair loss ( FPHL ).
Premature discontinuation of treatment commonly occurs because of the lack of perceived efficacy, adverse effects, or altered hair texture.
Low-dose ( 0.25-1.25 mg/d ) oral Minoxidil has been reported to be effective for female-pattern hair loss.
To date, no study has compared the relative efficacy of oral Minoxidil and topical Minoxidil in the treatment of female-pattern hair loss.
Researchers have performed a 24-week, randomized, open comparative study of 1 mg oral Minoxidil versus topical Minoxidil 5% solution for the treatment of female-pattern hair loss at a dermatology clinic ( Universidade Estadual Paulista - UNESP, Botucatu, São Paulo, Brazil ).
Women 18-65 years of age with FPHL ( Sinclair stage II-IV ) were randomly assigned to receive 1 mg oral Minoxidil or topical Minoxidil 5% solution ( 1 mL ) once daily for 24 weeks.
The primary endpoint was change in total hair density in a target area ( parietal ) from baseline to week 24.
Secondary outcomes were change in terminal hair density, global photographic evaluation ( by 3 board-certified dermatologists ), quality-of-life evaluation with the Women's Androgenetic Alopecia Quality of Life Questionnaire, and Sinclair hair shedding score ( 6-point scale ).
Intention-to-treat ( ITT ) analysis was performed.
52 participants were enrolled. Baseline characteristics were similar between the 2 groups, and 50 participants completed the trial.
Dropouts were not related to treatment side effects.
After 24 weeks of treatment, the total hair density increased by 12% ( 95% confidence interval [ CI ] 8.0-16.1% ) in women taking oral Minoxidil and 7.2% ( 95% CI 1.5-12.9% ) in women applying topical Minoxidil, a nonsignificant difference ( P = 0.09 ).
Scalp pruritus affected 19% of participants in the topical Minoxidil group.
Pretibial edema occurred in 4% of participants in the oral Minoxidil group.
Hypertrichosis was more common with oral Minoxidil ( 27% oral vs 4% topical ), although this side effect was mild and well tolerated; 3 participants did not take any action to remove the excess hair, and 5 managed it with waxing.
There was no difference between the groups regarding the variation of mean blood pressure over time. No hypotension-related events occurred.
The mean heart rate at rest increased 6.5% in the oral Minoxidil group without tachycardia; there was no change in the topical Minoxidil group.
No adverse events in oral Minoxidil group required cessation of medication.
These results have revealed that low-dose oral Minoxidil provides improvement of female-pattern hair loss that does not differ from topical Minoxidil 5% solution, with a safe profile and well-tolerated adverse effects.
The performance of oral minoxidil in regard to the Sinclair hair shedding score was superior to that of topical Minoxidil, reinforcing the favorable results reported with telogen effluvium.
The increase in total hair density lay within the topical minoxidil 95% CI; however, if the outcomes are taken together, they suggest a trend toward a greater improvement in the oral Minoxidil group.
In conclusion, oral Minoxidil can be considered an option for FPHL patients with poor compliance or who cannot tolerate topical Minoxidil. ( Xagena )
Müller Ramos P et al, J Am Acad Dermatol 2020;82:252-253