BRIDGEWATER - Bausch Health Companies Inc. (NYSE/TSX: BHC) and its dermatology business, Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced that the Journal of Drugs in Dermatology (JDD) published positive results from two large Phase 3, multicenter, double-blind, placebo-controlled clinical trials (Studies 1 and 2) demonstrating the efficacy, safety and tolerability of ARAZLOTM (tazarotene) Lotion, 0.045%, the first FDA approved tazarotene in lotion form for patients with moderate to severe acne.1

A post hoc analysis of male patients in the two Phase 3 studies was also published by JDD.2 The U.S. Food and Drug Administration (FDA) approved ARAZLO for the topical treatment of acne vulgaris in patients nine years of age and older in December 2019.

'When treating moderate to severe acne, I like to prescribe a tazarotene treatment due to the retinoid's efficacy, but find patients often struggle with tolerability issues, such as dry, irritated skin,' said Emil A. Tanghetti, M.D., lead ARAZLO study investigator and founder, Center for Dermatology and Laser Surgery, Sacramento, Calif. 'This newly published data sheds light on the utility of ARAZLO, a new treatment option that features the efficacy of tazarotene along with improved tolerability in a lotion vehicle, which is easily spreadable and aesthetically pleasing. I look forward to offering this treatment to my patients with acne in the coming months.'

The first primary endpoint in the pivotal studies (Studies 1 and 2) was treatment success (defined as those with at least a two-grade improvement in Evaluator's Global Severity Score (EGSS), and 'clear' or 'almost clear' skin) measured at week 12. The data showed that ARAZLO was more effective, with 25.5 percent and 29.6 percent of patients achieving treatment success compared with 13.0 percent and 17.3 percent in the placebo arms of Studies 1 and 2, respectively (p

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