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

September 2005 | Volume 4 | Issue 5 | Original Article | 592 | Copyright © September 2005

Helen Torok MD, Susan Taylor MD, Leslie Baumann MD, Terry Jones MD, Joshua Wieder MD, Nicholas Lowe MD, Michael Jarret MD, Pheobe Rich MD, David Pariser MD, Eduardo Tschen MD, Dale Martin MD, Alan Menter MD, Jonathan Weiss

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.