Phase 4 Study to Assess Tretinoin Pump for the Treatment of Facial Acne
December 2008 | Volume 7 | Issue 12 | Original Article | 1129 | Copyright © December 2008
Lawrence F. Eichenﬁeld MD, Marge Nighland BS, Ana Beatris Rossi MD, Fran Cook-Bolden MD, Pearl Grimes MD, Richard Fried MD PhD, Sharon Levy, PUMP Study Group
AbstractIt is well known that the setting of clinical trials for registration studies do not necessarily represent efﬁcacy seen in clinical practice, where physicians have the ﬂexibility to select, combine, and change the acne treatment prescription. In this phase 4, open-label, multicenter, community-based study, 544 patients who were dissatisﬁed with their current acne treatment received tretinoin gel mi- crosphere (TGM) 0.04% or 0.1% in a pump dispenser for 12 weeks. Patients were allowed the use of up to 2 other concurrent acne therapies, not including other retinoids. A total of 361 patients received TGM 0.04% and 183 received TGM 0.1%. Compliance was high (deﬁned as 75% to 100% of prescribed doses taken) for approximately 95% of patients in both groups at every evaluation. At week 12, the mean modiﬁed Global Acne Grade score (mGAGs) and the investigator global evaluation (IGE) demonstrated signiﬁcant (P<.0001) improvement from baseline for both concentrations, with 72% having at least moderate improvement. In approximately 25% of patients, acne was assessed as cleared or almost cleared. Most side effects were characteristic of topical retinoids. These results indicate TGM in a pump dispenser as an effective, well-tolerated acne treatment that is associated with a high rate of compli- ance.