Hydroquinone 4%, tretinoin 0.05%, fluocinolone acetonide 0.01%: a safe and efficacious 12-month treatment for melasma

This article describes a long-term, multicenter, open-label, 12-month study of once-daily fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% (Tri-Luma Cream, hereinafter called TC [triple combination]) application in the treatment of melasma. A total of 228 patients with facial melasma w...

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Bibliographic Details
Published inCutis (New York, N.Y.) Vol. 75; no. 1; p. 57
Main Authors Torok, Helen Mary, Jones, Terry, Rich, Phoebe, Smith, Stacy, Tschen, Eduardo
Format Journal Article
LanguageEnglish
Published United States 01.01.2005
Subjects
Antioxidants - therapeutic use
Drug Combinations
Facial Dermatoses - drug therapy
Female
Fluocinolone Acetonide - therapeutic use
Glucocorticoids - therapeutic use
Humans
Hydroquinones - therapeutic use
Keratolytic Agents - therapeutic use
Male
Melanosis - drug therapy
Middle Aged
Ointments
Treatment Outcome
Tretinoin - therapeutic use
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Summary:This article describes a long-term, multicenter, open-label, 12-month study of once-daily fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% (Tri-Luma Cream, hereinafter called TC [triple combination]) application in the treatment of melasma. A total of 228 patients with facial melasma were enrolled and treated; 173 patients (76%) completed the study. Most patients had 1 to 2 courses of treatment lasting approximately 6 months in total. TC cream showed a favorable safety profile. only 3 patients (1%) withdrew from the study due to treatment-related adverse events (AEs). A total of 129 patients (57%) experienced at least one treatment-related AE. Most AEs were expected application-site reactions that were mild and transient in nature and did not require remedial therapy. There were no cases of skin atrophy or skin thinning and only 6 cases of telangiectasia (5 mild and 1 moderate), most of which had improved by the end of the study. Results of the efficacy assessments were positive, with both the patient and the physician assessing melasma to be either completely or nearly cleared by the end of the study in more than 90% of cases. In this study, a once-daily application of TC cream over an extended period of 12 months showed no notable safety concerns and offered an effective treatment for melasma.
ISSN:0011-4162