Phase III studies of Altreno for acne published in Journal of Drugs in Dermatology.- Bausch Health + Ortho Dermatologics.

Bausch Health and Ortho Dermatologics announced that the Journal of Drugs in Dermatology has published results of two identical Phase III, multicenter, randomized, double-blind, vehicle-controlled, parallel group studies examining the efficacy and safety of Altreno (tretinoin) Lotion, 0.05%, the first formulation of tretinoin, a retinoid, in a lotion indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. 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 in a global severity by Evaluator Global Severity Score (EGSS) and 'clear' or 'almost clear' skin. By week 12, 17.7 percent of Altreno Lotion patients had achieved treatment success, compared to 9.3 percent of patients receiving vehicle.

Altreno Lotion also demonstrated statistically significant reductions in both inflammatory and noninflammatory lesion counts at week 12 compared to vehicle (52.1 percent versus 41.0 percent for inflammatory lesion counts and 46.1 percent versus 29.9 percent in noninflammatory lesion counts). The most common adverse reactions were application site pain (3.1 percent), dryness (3.7 percent) and erythema (1.4 percent). Altreno Lotion was found to be generally well-tolerated among treatment groups.

See: "Novel Tretinoin 0.05% Lotion for the Once-Daily Treatment of Moderate-to-Severe Acne Vulgaris; Assessment of Efficacy and Safety in Patients Aged 9 Years and Older." Tyring, Stephen K. et al. Journal of Drugs in Dermatology. 17(10):2018. 602-609.