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

Abstract

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.

• Authors: R Balkrishnan, A P Kelly, A McMichael, H Torok
• Journal: Journal of drugs in dermatology : JDD (J Drugs Dermatol) 2004 Jul-Aug Vol. 3 Issue 4 Pg. 377-81 ISSN: 1545-9616 [Print] United States
• PMID: 15303781 (Publication Type: Clinical Trial, Clinical Trial, Phase IV, Comparative Study, Journal Article, Multicenter Study)

Chemical References

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

Topics

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