title: 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.
abstract: 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.
authors.affiliation: Trillium Creek Dermatology, Inc, Medina, OH 44526, USA. helenmtorok@aol.com
authors.forename: Helen
authors.initials: H
authors.lastname: Torok
authors.forename: Susan
authors.initials: S
authors.lastname: Taylor
authors.forename: Leslie
authors.initials: L
authors.lastname: Baumann
authors.forename: Terry
authors.initials: T
authors.lastname: Jones
authors.forename: Joshua
authors.initials: J
authors.lastname: Wieder
authors.forename: Nicholas
authors.initials: N
authors.lastname: Lowe
authors.forename: Michael
authors.initials: M
authors.lastname: Jarret
authors.forename: Pheobe
authors.initials: P
authors.lastname: Rich
authors.forename: David
authors.initials: D
authors.lastname: Pariser
authors.forename: Eduardo
authors.initials: E
authors.lastname: Tschen
authors.forename: Dale
authors.initials: D
authors.lastname: Martin
authors.forename: Alan
authors.initials: A
authors.lastname: Menter
authors.forename: Jonathan
authors.initials: J
authors.lastname: Weiss
mesh_terms: D000287:Administration, Topical; D000328:Adult; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005446:Fluocinolone Acetonide / Q000008:administration & dosage / Q000627:therapeutic use; D006801:Humans; D006873:Hydroquinones / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D007641:Keratolytic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D008548:Melanosis / Q000188:drug therapy*; D008875:Middle Aged; D014212:Tretinoin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D003879:Dermatologic Agents; D004338:Drug Combinations; D006873:Hydroquinones; D007641:Keratolytic Agents; D005446:Fluocinolone Acetonide; D014212:Tretinoin; C031927:hydroquinone