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 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.
Torok
Helen Mary
HM
HMT Dermatology Associates, Inc, Medina, Ohio, USA. helenmtorok@aol.com
Jones
Terry
T
Rich
Phoebe
P
Smith
Stacy
S
Tschen
Eduardo
E
D000975:Antioxidants / Q000627:therapeutic use; D004338:Drug Combinations; D005148:Facial Dermatoses / Q000188:drug therapy*; D005260:Female; D005446:Fluocinolone Acetonide / Q000627:therapeutic use; D005938:Glucocorticoids / Q000627:therapeutic use; D006801:Humans; D006873:Hydroquinones / Q000627:therapeutic use; D007641:Keratolytic Agents / Q000627:therapeutic use; D008297:Male; D008548:Melanosis / Q000188:drug therapy*; D008875:Middle Aged; D009824:Ointments; D016896:Treatment Outcome; D014212:Tretinoin / Q000627:therapeutic use
D000975:Antioxidants; D004338:Drug Combinations; D005938:Glucocorticoids; D006873:Hydroquinones; D007641:Keratolytic Agents; D009824:Ointments; D005446:Fluocinolone Acetonide; D014212:Tretinoin; C031927:hydroquinone