Improved quality of life with effective treatment of facial melasma: the pigment trial

J Drugs Dermatol. Jul-Aug 2004;3(4):377-81.


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.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase IV
  • Comparative Study
  • Multicenter Study

MeSH terms

  • Administration, Cutaneous
  • Adult
  • Dermatologic Agents / administration & dosage
  • Dermatologic Agents / therapeutic use*
  • Drug Combinations
  • Face
  • Female
  • Fluocinolone Acetonide / administration & dosage
  • Fluocinolone Acetonide / therapeutic use*
  • Humans
  • Hydroquinones / administration & dosage
  • Hydroquinones / therapeutic use*
  • Male
  • Melanosis / drug therapy*
  • Melanosis / psychology
  • Ointments
  • Prospective Studies
  • Quality of Life*
  • Surveys and Questionnaires
  • Treatment Outcome
  • Tretinoin / administration & dosage
  • Tretinoin / therapeutic use*


  • Dermatologic Agents
  • Drug Combinations
  • Hydroquinones
  • Ointments
  • Fluocinolone Acetonide
  • Tretinoin
  • hydroquinone