PMID- 16167418 OWN - NLM STAT- MEDLINE DCOM- 20051026 LR - 20161124 IS - 1545-9616 (Print) IS - 1545-9616 (Linking) VI - 4 IP - 5 DP - 2005 Sep-Oct TI - A large 12-month extension study of an 8-week trial to evaluate the safety and efficacy of triple combination (TC) cream in melasma patients previously treated with TC cream or one of its dyads. PG - 592-7 AB - This was a 12-month extension of a randomized, investigator-blinded, multicenter, 8-week trial with triple combination (TC) cream in facial melasma. A total of 585 patients were enrolled in the study and 569 patients received study medication. Three hundred eighty-nine patients completed 6 months of treatment and 327 patients completed 12 months of treatment. TC cream demonstrated a favorable safety profile: only 14 patients (2.5%) discontinued the study due to treatment-related adverse events (AEs). The 2 cases of skin atrophy were mild and did not lead to withdrawal. From the 23 cases of mild telangiectasia, only 2 resulted in discontinuation. All others were transient. Results confirmed those of a previous smaller study, with both physicians and patients reporting clinically significant improvements in melasma. By month 12, 80% of patients had lesions completely cleared or nearly cleared. Once daily application of TC cream applied intermittently over a long period is a safe, tolerable, and effective treatment for moderate to severe melasma of the face. FAU - Torok, Helen AU - Torok H AD - Trillium Creek Dermatology, Inc, Medina, OH 44526, USA. helenmtorok@aol.com FAU - Taylor, Susan AU - Taylor S FAU - Baumann, Leslie AU - Baumann L FAU - Jones, Terry AU - Jones T FAU - Wieder, Joshua AU - Wieder J FAU - Lowe, Nicholas AU - Lowe N FAU - Jarret, Michael AU - Jarret M FAU - Rich, Pheobe AU - Rich P FAU - Pariser, David AU - Pariser D FAU - Tschen, Eduardo AU - Tschen E FAU - Martin, Dale AU - Martin D FAU - Menter, Alan AU - Menter A FAU - Weiss, Jonathan AU - Weiss J LA - eng PT - Clinical Trial PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - United States TA - J Drugs Dermatol JT - Journal of drugs in dermatology : JDD JID - 101160020 RN - 0 (Dermatologic Agents) RN - 0 (Drug Combinations) RN - 0 (Hydroquinones) RN - 0 (Keratolytic Agents) RN - 0CD5FD6S2M (Fluocinolone Acetonide) RN - 5688UTC01R (Tretinoin) RN - XV74C1N1AE (hydroquinone) SB - IM MH - Administration, Topical MH - Adult MH - Dermatologic Agents/administration & dosage/adverse effects/*therapeutic use MH - Double-Blind Method MH - Drug Combinations MH - Female MH - Fluocinolone Acetonide/administration & dosage/therapeutic use MH - Humans MH - Hydroquinones/administration & dosage/adverse effects/therapeutic use MH - Keratolytic Agents/administration & dosage/adverse effects/therapeutic use MH - Male MH - Melanosis/*drug therapy MH - Middle Aged MH - Tretinoin/administration & dosage/adverse effects/therapeutic use EDAT- 2005/09/20 09:00 MHDA- 2005/10/27 09:00 CRDT- 2005/09/20 09:00 PHST- 2005/09/20 09:00 [pubmed] PHST- 2005/10/27 09:00 [medline] PHST- 2005/09/20 09:00 [entrez] PST - ppublish SO - J Drugs Dermatol. 2005 Sep-Oct;4(5):592-7.