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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