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2015 ; 9
(ä): 4219-25
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The first clinical experience on efficacy of topical flutamide on melasma
compared with topical hydroquinone: a randomized clinical trial
#MMPMID26345129
Adalatkhah H
; Sadeghi-Bazargani H
Drug Des Devel Ther
2015[]; 9
(ä): 4219-25
PMID26345129
show ga
BACKGROUND: Treatment of melasma is unsatisfactory most of the times. Hormonal
role is shown to exist in pathogenesis of the melasma, and sex-hormone related
drugs may have an effect on melasma. AIM: To investigate efficacy of 1% flutamide
cream versus 4% hydroquinone cream on melasma. METHODS: In a parallel randomized
clinical trial, 74 women with melasma were allocated to receive a sunscreen along
with 4% hydroquinone cream or 1% flutamide cream. Melasma Area and Severity Index
(MASI), mexameter melanin assay, and patient satisfaction were investigated.
RESULTS: Mean age of the participants was 33.8 years. Mean length of time
suffering from Melasma was 96.3 months. The subjects reported in average 1.1
hours per day of exposure to sunlight. Mean standardized total patient
satisfaction score was 28.8 (standard deviation [SD] 17.2) in flutamide group
patients versus 18 (SD 15.5) in control group (P<0.01). Regardless of treatment
group, the skin darkness assessed upon MASI scales was reduced over the treatment
course (P<0.001). Using mixed effects, longitudinal modeling showed better
treatment efficacy based on MASI scale for flutamide group compared to the
hydroquinone group (P<0.05). However, longitudinal analysis of mexameter scores
did not reveal any significant difference in melanin measurements between
flutamide and hydroquinone. CONCLUSION: Topical flutamide appeared as effective
as topical hydroquinone in treating melasma using mexameter assessment but with a
better MASI improvement trend and higher patient satisfaction in flutamide
treatment versus topical hydroquinone. As the present study is possibly the first
clinical experience on efficacy of topical flutamide on melasma, it would be
quite unreasonable to recommend clinical use of it before future studies
replicate the results on its efficacy and safety.