Community-Based Trial of a Triple-Combination Agent for the Treatment of Facial Melasma

Melasma is a common hyperpigmentation disorder that is frequently recalcitrant to treatment. An 8-week, multicenter, open-label, community-based study evaluated a new therapeutic approach that combines tretinoin 0.05%, hydroquinone 4.0%, and fluocinolone acetonide 0.01% (RA+HQ+FA) in a hydrophilic cream formulation. The trial enrolled 1290 patients of diverse races/ethnicities with a full range of Fitzpatrick skin types (I through VI). The mean Melasma Area and Severity Index (MASI) decreased significantly at both weeks 4 and 8 compared with baseline in the overall study population and across all Fitzpatrick skin types and races/ethnicities (P