July 2011

The 5% minoxidil foam approved for treatment of male androgenetic alopecia demonstrated significant clinical advantages over 2% minoxidil topical solution in the first head-to-head comparative trial conducted in women with the hair disorder.

The 5% minoxidil foam is approved as once-daily therapy in men only. The twice-daily 2% topical solution is the sole medication approved in the United States and Europe for female androgenetic alopecia.

But in the randomized trial, the once-daily 5% foam earned higher marks from women in terms of cosmetic acceptance, convenience, and tolerability while demonstrating efficacy similar to that of the twice-daily 2% solution, Dr. Ulrike Blume-Peytavi reported at the World Congress of Dermatology.

She presented a 24-week, investigator-blinded, prospective, multicenter, randomized trial of 5% minoxidil foam once daily versus 2% minoxidil solution twice daily in 113 patients with female-pattern hair loss. The primary end point was the change from baseline to week 24 in terms of nonvellus target-area hair count as measured by Canfield hair matrix image analysis.

Patients assigned to the 5% foam had a mean 32-hair/cm2 or 16% increase, not significantly different from the 14% increase documented in women on the 2% topical solution.

In terms of secondary end points, global photographic review by blinded expert evaluators rated 68% of women in the 5% foam group as having achieved increased hair volume, and a similar 56% of those who received the 2% solution. Nor were the subjects' own efficacy ratings significantly different between the two groups, according to Dr. Blume-Peytavi of the Clinical Research Center for Hair and Skin Science at Charité University, Berlin.

Women randomized to 5% minoxidil foam experienced significantly lower rates of treatment intolerance, particularly with regard to itching and dandruff. Sixteen percent of them reported significant pruritus, compared with 39% of women on the 2% minoxidil solution. Just 5% of the women on the 5% minoxidil foam complained of dandruff, compared with 18% on the 2% solution. There were, however, no significant differences between the study arms in terms of complaints of redness, stinging, or dryness.

On a cosmetic acceptability questionnaire, 46% of the 5% minoxidil foam group strongly indicated that the medication did not interfere with styling their hair, compared with just 19% of women on the 2% topical solution.

The reason Dr. Blume-Peytavi and coinvestigators undertook this trial was to test their hypothesis that the minoxidil foam would be better tolerated and more cosmetically acceptable because, unlike the 2% topical solution, it is free of propylene glycol. They also thought the foam product would be significantly more effective at stimulating new hair growth because of its higher minoxidil concentration, although this proved not to be the case.

Dr. Blume-Peytavi is a consultant to Johnson & Johnson and Procter & Gamble.

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