Original article
A randomized, single-blind trial of 5% minoxidil foam once daily versus 2% minoxidil solution twice daily in the treatment of androgenetic alopecia in women

https://doi.org/10.1016/j.jaad.2010.09.724Get rights and content

Background

Although twice-daily application of propylene glycol–containing 2% minoxidil topical solution (MTS) stimulates new hair growth, higher concentrations of minoxidil in a once-daily, propylene glycol–free formulation may improve efficacy and reduce unpleasant side effects.

Objective

We sought to compare the efficacy, safety, and acceptability and to show noninferiority of once-daily 5% minoxidil topical foam (MTF) with twice-daily 2% MTS in women with androgenetic alopecia.

Methods

A total of 113 women with androgenetic alopecia were randomized to 24 weeks of treatment with 5% MTF or 2% MTS. The primary efficacy parameter was change from baseline in nonvellus target area hair count at week 24. Secondary end points included change in nonvellus target area hair width, overall efficacy by global photographic review as assessed by treatment-blinded evaluators and the subject herself, adverse events, and participants' assessment of product aesthetics.

Results

After 24 weeks, women randomized to 5% MTF once daily showed noninferior target area hair count and target area hair width and experienced greater, but nonsignificant, improvements in target area hair count, target area hair width, and overall efficacy by global photographic review than those randomized to 2% MTS used twice daily. 5% MTF was significantly superior to 2% MTS in participants' agreement with “the treatment does not interfere with styling my hair” (P = .002). Women randomized to 5% MTF experienced significantly lower rates of local intolerance (P = .046) especially in pruritus and dandruff compared with 2% MTS.

Limitation

Because of differences in the formulations tested, study participants were not blinded to treatment.

Conclusions

Once-daily 5% MTF is noninferior and as effective for stimulating hair growth as twice-daily 2% MTS in women with androgenetic alopecia and is associated with several aesthetic and practical advantages.

Section snippets

Study design

This was a 24-week, randomized, investigator-initiated and -blinded, 2-arm comparative study conducted at a single site to evaluate the efficacy and safety of once-daily 5% MTF versus twice-daily 2% MTS in women with AGA. The study design did not include a placebo arm on ethical grounds as there are a number of therapeutic options available to women with AGA and previous studies of minoxidil in women with AGA provide suitable and extensive comparative data on hair growth in participants

Participants

A total of 114 women with AGA in the centroparietal region were enrolled in the study (Fig 1). One enrolled participant was not randomized to treatment because of an existing pregnancy. The participants ranged from 23 to 75 years in age (mean: 49.9 years) (Table I; available online at http://www.eblue.org). The majority of participants were white (95.6%). The mean Savin hair density score at baseline was 4.13 in the 5% MTF arm and 3.84 in the 2% MTS arm. There was a higher proportion of

Discussion

AGA may have significant impact for quality of life in female patients. Treatments to clinically improve scalp hair density and reduce midpattern thinning leading to improved scalp coverage are highly important for the affected women. This 24-week, randomized, investigator-initiated, blinded study compared a once-daily 5% MTF formulation with the twice-daily 2% MTS formulation currently available for treating women with AGA. Different aspects were analyzed: GPR by participants and investigators

References (18)

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    Hair loss is a disorder in which the hair falls out from skin areas where they are usually present, such as the scalp and the body [4]. This loss interferes with the many useful biologic functions of the hair like sun protection (mainly to the scalp) and dispersal of sweat gland products [4]. Current United States Food and Drug Administration (FDA)-approved treatment options for hair loss are restricted to topical Minoxidil (for men and women), oral Finasteride (men only), and low-level light therapy (men and women) [2,9].

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The first two authors contributed equally to the study and preparation of this manuscript.

Supported by a medical grant application, Johnson & Johnson Consumer Co Inc.

Disclosure: Dr Blume-Peytavi is a consultant for Johnson & Johnson Consumer Co Inc. Dr Garcia Bartels was a consultant for Pfizer GmbH Germany until 2008. Dr Hillmann, Dr Dietz, and Mr Canfield have no conflicts of interest to declare.

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