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

• Published in: Journal of drugs in dermatology Vol. 4; no. 5; p. 592
• Main Authors: Torok, Helen, Taylor, Susan, Baumann, Leslie, Jones, Terry, Wieder, Joshua, Lowe, Nicholas, Jarret, Michael, Rich, Pheobe, Pariser, David, Tschen, Eduardo, Martin, Dale, Menter, Alan, Weiss, Jonathan
• Format: Journal Article
• Language: English
• Published: United States 01.09.2005
• Subjects: Administration, Topical; Adult; Dermatologic Agents - administration & dosage; Dermatologic Agents - adverse effects; Dermatologic Agents - therapeutic use; Double-Blind Method; Drug Combinations; Female; Fluocinolone Acetonide - administration & dosage; Fluocinolone Acetonide - therapeutic use; Humans; Hydroquinones - administration & dosage; Hydroquinones - adverse effects; Hydroquinones - therapeutic use; Keratolytic Agents - administration & dosage; Keratolytic Agents - adverse effects; Keratolytic Agents - therapeutic use; Male; Melanosis - drug therapy; Middle Aged; Tretinoin - administration & dosage; Tretinoin - adverse effects; Tretinoin - therapeutic use
• ISSN: 1545-9616

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.