Efficacy and Safety of Once-Daily Minoxidil Foam 5% Versus Twice-Daily Minoxidil Solution 2% in Female Pattern Hair Loss: A Phase III, Randomized, Investigator-Blinded Study
July 2016 | Volume 15 | Issue 7 | Original Article | 883 | Copyright © July 2016
Ulrike Blume-Peytavi MD,a Jerry Shapiro MD,b Andrew G. Messenger MD,c Maria K. Hordinsky MD,d Paul Zhang PhD,e Carlos Quiza MD,e Uday Doshi PhD,e and Elise A. Olsen MDf
aDepartment of Dermatology and Allergy, Charité – Universitätsmedizin, Berlin, Germany
bRonald O. Perlman Department of Dermatology, New York University Langone Medical Center, New York, NY
cDepartment of Dermatology, Royal Hallamshire Hospital, Sheffield, United Kingdom
dDepartment of Dermatology, University of Minnesota, Minneapolis, MN
eJohnson & Johnson Consumer Inc., Morris Plains, NJ
fDepartments of Dermatology and Medicine, Duke University Medical Center, Durham, NC
OBJECTIVE: Determine noninferiority of once-daily 5% MTF versus twice-daily 2% minoxidil topical solution (MTS) based on the change from baseline in target area hair count (TAHC) at 24 weeks. METHODS: In a randomized, phase III trial, women with female pattern hair loss received once-daily 5% MTF (n=161) or twice-daily 2% MTS (n=161) for 52 weeks. Primary endpoint was change from baseline in TAHC at 24 weeks. Secondary endpoint was change from baseline in TAHC at 12 weeks. Exploratory endpoints included change in total unit area density and change in overall scalp coverage.
RESULTS: Once-daily 5% MTF increased TAHC from baseline (adjusted mean ± standard error) by 23.9 ± 2.1 hairs/cm2 at week 24. Twice-daily 2% MTS increased TAHC 24.2 ± 2.1 hairs/cm2 at week 24. The treatment difference was –0.3 hairs/cm2 (95% CI = –6.0, 5.4). Since the lower bound of the 95% CI was less than –5.0, the prespecified noninferiority goal was not met. Both treatments were well tolerated.
CONCLUSIONS: Once-daily 5% MTF and twice-daily 2% MTS induced hair regrowth in female pattern hair loss, but prespecified noninferiority criteria were not met.
ClinicalTrials.gov identifier: NCT01145625
J Drugs Dermatol. 2016;15(7):883-889.