Placebo‐controlled dose‐effect studies with topical minoxidil 2% or 5% in male‐patterned hair loss treated with oral finasteride employing an analytical and exhaustive study protocol

BACKGROUND: Drug trials for male‐pattern hair loss (MPHL) did not investigate hair cycling. MATERIALS AND METHODS: Male‐pattern hair loss volunteers (n = 22) took oral finasteride 1 mg daily with randomly either MTS5% or control lotion (1 mL/d). After 12 months on oral drug, 14 were randomized for a dose‐effect study of topical minoxidil 2% or 5%. Each 3‐month “on‐lotion” was followed by a 3‐month “off‐lotion.” RESULTS: Exogen release and anagen initiation from pre‐existing but functionally deficient follicles occurred mainly during combined dug treatment. Anagen initiation by topical minoxidil 5% could not be maintained by oral finasteride. As compared with control males, the compound index of hair growth raised from 30% at baseline up to 60% within 3 months of combined drug regimen which is better than oral drug only (no change) but still far beyond normalization of productivity (considered as 100%). There was no obvious transformation of miniaturized hair follicles into terminal hair‐producing follicles, and the activation of miniaturized hair follicles was not clinically relevant (slow growth and short duration of anagen). CONCLUSIONS: Benefit with oral finasteride and topical 5% minoxidil (1 mL, 1 per day) resulted from initiation of anagen in deficient terminal follicles without increased growth rates.