A Phase III, Multicenter, Parallel-Design Clinical Trial to Compare the Efficacy and Safety of 5% Minoxidil Foam Versus Vehicle in Women With Female Pattern Hair Loss
July 2016 | Volume 15 | Issue 7 | Original Article | 874 | Copyright © 2016
Wilma Bergfeld MD,a Ken Washenik MD PhD,b,c Valerie Callender MD,d Paul Zhang PhD,e Carlos Quiza MD,e Uday Doshi PhD,e and Ulrike Blume-Peytavi MDf
aDepartments of Dermatology and Pathology, Cleveland Clinic, Cleveland, OH
bBosley Medical Groups, Beverly Hills, CA
cDepartment of Dermatology, New York University School of Medicine, New York, NY
dCallender Dermatology and Cosmetic Center, Glenn Dale, MD
eJohnson & Johnson Consumer, Inc. Skillman, NJ
fDepartment of Dermatology and Allergy, Charité – Universitätsmedizin Berlin, Germany
BACKGROUND Female pattern hair loss (FPHL) is a common hair disorder that affects millions of women. A new 5% minoxidil topical foam (MTF) formulation, which does not contain propylene glycol, has been developed.
OBJECTIVE: To compare the efficacy and safety of once-daily 5% MTF with vehicle foam for the treatment of FPHL.
MATERIALS AND METHODS: This was a Phase III, randomized, double-blind, vehicle-controlled, parallel-group, international multicenter trial (17 sites) in women aged at least 18 years with FPHL (grade D3 to D6 on the Savin Density Scale), treated once daily with 5% MTF or vehicle foam for 24 weeks. The co-primary efficacy endpoints were the change from baseline at week 24 in target area hair count (TAHC) and subject assessment of scalp coverage. Also evaluated were TAHC at week 12, expert panel review of hair regrowth at week 24, and change from baseline in total unit area density (TUAD, sum of hair diameters/cm2) at weeks 12 and 24.
RESULTS: A total of 404 women were enrolled. At 12 and 24 weeks, 5% MTF treatment resulted in regrowth of 10.9 hairs/cm2 and 9.1 hairs/cm2 more than vehicle foam, respectively (both P<.0001). Improved scalp coverage at week 24 was observed by both subject self-assessment (0.69-point improvement over vehicle foam; P<.0001) and expert panel review (0.36-point improvement over the vehicle foam; P<.0001). TUAD increased by 658 μm/cm2 and 644 μm/cm2 more with 5% MTF than with vehicle foam at weeks 12 and 24, respectively (both P<.0001). MTF was well tolerated. A low incidence of scalp irritation and facial hypertrichosis was observed, with no clinically significant differences between groups.
CONCLUSION: Five percent MTF once daily for 24 weeks was well tolerated and promoted hair regrowth in women with FPHL, resulting in improved scalp coverage and increased hair density compared with vehicle foam. ClinicalTrials.gov identifier: nCT01226459
J Drugs Dermatol. 2016;15(7):874-881.
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Female pattern hair loss (FPHL) is a common hair disorder of the central scalp that affects millions of women.1,2 It causes a significant social and psychological impact, which is generally not seen with male pattern hair loss, including loss of self-confidence, reduced self-image, and emotional distress.2,3
Minoxidil topical solution (MTS) has been used to treat pattern hair loss, effectively increasing hair regrowth, independently of changes in local blood flow.4,5 Although the exact mechanism is unclear, minoxidil is thought to promote hair regrowth by opening adenosine triphosphate-sensitive potassium channels and consequently stimulating prostaglandin synthase-1, vascular endothelial growth factor, and other growth promoters in dermal papilla.2,5-8 Although effective and generally well tolerated, 2% MTS has been associated with adverse effects,4 including contact dermatitis, most likely due to the solvent propylene glycol, a potential skin irritant.9-11
Recently, a new 5% minoxidil topical foam (MTF) formulation has been developed, which is approved for over-the-counter use.12,13 It is a patented, hydroalcoholic, propylene glycol–free formula that is thermolabile and designed to melt at body temperature, facilitating application to the scalp.14,15 Although minoxidil dosing for hair loss historically has been twice-daily, once-daily dosing is feasible, as the half-life of minoxidil after topical dosing is estimated to be 25 hours.16