Ortho Dermatologics, the dermatology division of Bausch Health Companies, has announced the U.S. launch of ALTRENO (tretinoin) Lotion, 0.05% for the topical treatment of acne vulgaris in patients 9 years of age and older. In clinical trials, ALTRENO Lotion was shown to be effective and generally well tolerated. The formulation includes known moisturizers hyaluronic acid, glycerin and collagen.
The U.S. Food and Drug Administration approved ALTRENO Lotion in August 2018, based on data from two identical multicenter, randomized, double-blind, vehicle-controlled Phase 3 studies that demonstrated statistically significant reductions in both inflammatory and non-inflammatory lesions compared to vehicle. In the studies, ALTRENO Lotion was shown to have significantly greater efficacy compared to vehicle in achieving treatment success, which was defined as at least a two-grade improvement from baseline and clear to almost clear in acne severity by Evaluator Global Severity Score (EGSS). The most common adverse reactions, occurring in >1% of subjects and greater than vehicle, were dryness, pain, erythema, irritation and exfoliation
“Many acne patients struggle using acne medications because they can cause irritation to the skin,” said Joshua Zeichner, MD, director of cosmetic and clinical research in dermatology at Mount Sinai Hospital, New York City. “ALTRENO Lotion has demonstrated the efficacy of a tretinoin with a proven tolerability profile. Greater tolerability may help improve adherence to skin care regimens, which may ultimately lead to better patient outcomes.”
