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<.0001). The mean MASI darkness and homogeneity scores likewise fell significantly at weeks 4 and 8 in all facial regions involved (forehead, right and left malar regions, and chin) and in all Fitzpatrick skin types (P<.0001). By week 8, investigators' global evaluations showed that 75% of patients had "moderate or marked improvement" or were "almost clear" or "clear." The study medication was found to be safe and well tolerated. The results of this study demonstrate that RA+HQ+FA produces significant rapid improvement of melasma across the range of patients seen in daily practice, including whites, Hispanics, blacks, Asians, American Indians, Alaskan natives, and Pacific Islanders.