COMPARATIVE EFFICACY AND SAFETY OF 2 0.025-PERCENT TRETINOIN GELS - RESULTS FROM A MULTICENTER, DOUBLE-BLIND, PARALLEL STUDY

Background: The addition of polyolprepolymer-2 in tretinoin formulatio ns may reduce tretinoin-induced cutaneous irritation. Objective: This study compared the efficacy and safety of a new 0.025% tretinoin gel c ontaining polyolprepolymer-2, its vehicle, and a commercially-availabl e 0.025% tretinoin gel in patients with mild to moderate acne vulgaris . Methods: In this 12-week multicenter, double-blind, parallel group s tudy, efficacy was evaluated by objective lesion counts and the invest igators' global evaluations. Subjective assessment of cutaneous irrita tion by the investigators and patients evaluated safety. Results: The efficacy of the two active treatments in this 215 patient study was co mparable, and both treatments were statistically significantly more ef fective than vehicle. When compared with the commercially-available tr etinoin gel, the formulation containing polyolprepolymer-2 demonstrate d statistically significantly less peeling at days 28, 56, and 84, sta tistically significantly less dryness by day 84, and statistically sig nificantly less itching at day 14. Irritation scores for the formulati on containing polyolprepolymer-2 were numerically lower but not statis tically different from those of the commercially-available gel for ery thema and burning. The number of cutaneous and noncutaneous adverse ev ents were similar for both active medications. Conclusion: The two 0.0 25% gels studied demonstrated comparable efficacy. However, the gel fo rmulation containing polyolprepolymer-2 caused significantly less peel ing and drying than the commercially-available formulation by day 84 o f the study.