We found no systematic review. We found three RCTs.
In Caucasian people: The first RCT was done in 50 Caucasian women with facial melasma.21 Pregnant or nursing women were excluded. Women attending tanning salons, having heavy sun exposure, or who had used systemic retinoids during the previous 6 months or topical retinoids during the previous month were excluded. The trial compared the daily use of topical 0-1% tretinoin with placebo (vehicle cream for tretinoin). The withdrawal rate was 24%. Insufficient baseline data was presented to determine if groups were comparable at baseline.
In Asian people: The second RCT17 included 30 Thai people (26 women and 4 men) with facial melasma. It excluded pregnant and nursing women, and people who had used systemic retinoids in the previous 6 months or topical retinoids in the previous month. The RCT compared a titrated daily application of 0-05% isotretinoin gel with colour-matched vehicle used as placebo, for 40 weeks. There were no significant differences in the MASI or MAMI scores in the evaluations done at 2 weeks, 4 weeks and monthly for up to 40 weeks. The only two participants with dermal melasma were allocated to the isotretinoin group. Participants in both groups improved during the 40-week follow up.
In black people: One RCT in the US compared the daily application to the entire face of a cream with 0-1% tretinoin or placebo (vehicle) in 30 (29 women) Afro-American black people, followed for 40 weeks.22 The MASI score was used to assess the severity of melasma. Darkness and homogeneity were also assessed. Colorimetry, photographic and histology studies were done before and after treatment. After 40 weeks people receiving tretinoin had higher rates of improvement in their mean ± SD MASI score (MASI score changed in the tretinoin group from 15-0 ± 1.8 at baseline to 10-2 ± 2 and in the vehicle group from 15-5 ± 2-6 to 13-9 ± 2-7 after 40 weeks of treatment (P=0-03).) Changes were assessed by an independent clinician, who found no significant differences between tretinoin and placebo after 24 weeks (improved or much improved: 11/15 (73%) with tretinoin compared with 6/13 (46%) with placebo; RR 1-6, CI 0-8-3-1).
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