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 © 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
BACKGROUND: A once-daily minoxidil topical foam (MTF) has been developed to treat female pattern hair loss.
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.
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Two percent minoxidil topical solution (MTS) applied twice daily was the first approved treatment for male and female hair loss.1 Recently, a topical foam formulation containing 5% minoxidil with a hydro-alcohol–based vehicle has been developed.2-4 Findings from an investigator-initiated, randomized, single-blind, 24-week trial in female pattern hair loss (FPHL) showed that once-daily minoxidil topical foam 5% (MTF) was as effective for stimulating hair growth as twice-daily 2% MTS in women, and was associated with a lower incidence of skin irritation and improved aesthetics.3 The current multicenter pivotal study was conducted to further determine the effects of once-daily 5% MTF versus twice-daily 2% MTS for the treatment of FPHL.
Study Design and Conduct
This was a 1-year, randomized, single-blind, phase III clinical trial of once-daily 5% MTF versus twice-daily 2% MTS in women with FPHL, conducted at 12 sites in the United States, Canada, France, Germany, and the United Kingdom from June 2010 to February 2012 (ClinicalTrials.gov identifier NCT01145625). The review boards of all participating institutions approved the study, which was performed in accordance with the International Conference on Harmonization Good Clinical Practice guidelines, and applicable local regulatory requirements and laws. All subjects provided written informed consent before participating in the study.
Eligible subjects were healthy women of at least 18 years of age with FPHL who scored between D3 and D6 on the Savin Density Scale (Figure 1).5,6 Other inclusion and exclusion criteria are shown in Table 1.
Subjects were randomized in a ratio of 1:1 to receive either 5% MTF or 2% MTS for 52 weeks in the order of their enrollment at