PMID- 15732437 OWN - NLM STAT- MEDLINE DCOM- 20050609 LR - 20161124 IS - 0011-4162 (Print) IS - 0011-4162 (Linking) VI - 75 IP - 1 DP - 2005 Jan TI - Hydroquinone 4%, tretinoin 0.05%, fluocinolone acetonide 0.01%: a safe and efficacious 12-month treatment for melasma. PG - 57-62 AB - 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. FAU - Torok, Helen Mary AU - Torok HM AD - HMT Dermatology Associates, Inc, Medina, Ohio, USA. helenmtorok@aol.com FAU - Jones, Terry AU - Jones T FAU - Rich, Phoebe AU - Rich P FAU - Smith, Stacy AU - Smith S FAU - Tschen, Eduardo AU - Tschen E LA - eng PT - Clinical Trial PT - Journal Article PT - Multicenter Study PL - United States TA - Cutis JT - Cutis JID - 0006440 RN - 0 (Antioxidants) RN - 0 (Drug Combinations) RN - 0 (Glucocorticoids) RN - 0 (Hydroquinones) RN - 0 (Keratolytic Agents) RN - 0 (Ointments) RN - 0CD5FD6S2M (Fluocinolone Acetonide) RN - 5688UTC01R (Tretinoin) RN - XV74C1N1AE (hydroquinone) SB - IM MH - Antioxidants/therapeutic use MH - Drug Combinations MH - Facial Dermatoses/*drug therapy MH - Female MH - Fluocinolone Acetonide/therapeutic use MH - Glucocorticoids/therapeutic use MH - Humans MH - Hydroquinones/therapeutic use MH - Keratolytic Agents/therapeutic use MH - Male MH - Melanosis/*drug therapy MH - Middle Aged MH - Ointments MH - Treatment Outcome MH - Tretinoin/therapeutic use EDAT- 2005/03/01 09:00 MHDA- 2005/06/10 09:00 CRDT- 2005/03/01 09:00 PHST- 2005/03/01 09:00 [pubmed] PHST- 2005/06/10 09:00 [medline] PHST- 2005/03/01 09:00 [entrez] PST - ppublish SO - Cutis. 2005 Jan;75(1):57-62.