Improved quality of life with effective treatment of facial melasma: the pigment trial.
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.
University of Texas Schools of Public Health and Medicine, Houston, Texas 77030, USA. Rajesh.balkrishnan@uth.tmc.edu
R
R
Balkrishnan
A P
AP
Kelly
A
A
McMichael
H
H
Torok
D000279:Administration, Cutaneous; D000328:Adult; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D004338:Drug Combinations; D005145:Face; D005260:Female; D005446:Fluocinolone Acetonide / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D006873:Hydroquinones / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008548:Melanosis / Q000188:drug therapy* / Q000523:psychology; D009824:Ointments; D011446:Prospective Studies; D011788:Quality of Life; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014212:Tretinoin / Q000008:administration & dosage / Q000627:therapeutic use*
D003879:Dermatologic Agents; D004338:Drug Combinations; D006873:Hydroquinones; D009824:Ointments; D005446:Fluocinolone Acetonide; D014212:Tretinoin; C031927:hydroquinone