Improved Quality of Life with Treatment of Facial Melasma: The Pigment Trial
July 2004 | Volume 3 | Issue 4 | Original Article | 377 | Copyright © July 2004
R Balkrishnan PhD, A P Kelly MD, A McMichael MD, H Torok MD
Melasma is a common hyperpigmentation of the face or neck that can have severe adverse psychological and emotional effects on
affected individuals. Although a variety of treatments have been used over the years, results have typically been less than satisfactory.
An open-label, community-based trial was undertaken at 393 centers in the United States, enrolling 1290 patients representing a
broad range of races/ethnicities and all Fitzpatrick skin types, to evaluate the efficacy and safety of a new melasma treatment that
combines fluocinolone acetonide 0.01%, hydroquinone 4.0%, and tretinoin 0.05% (FA+HQ+RA) in a hydrophilic cream formulation.
An additional objective of the study was to assess the impact of this therapy on the quality of life. Efficacy and safety were evaluated
at 4 and 8 weeks, and changes in a variety of quality of life parameters were analyzed at the conclusion of the study. All measures
of efficacy showed that FA+HQ+RA significantly (p<0.0001) improved melasma at 4 weeks with further improvement at 8 weeks across
all races/ethnicities and Fitzpatrick skin types. The treatment was safe and well tolerated. After 8 weeks of therapy, patients reported
that FA+HQ+RA had provided a variety of benefits that had enhanced their quality of life.