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.