Study: Positive Safety and Tolerability Results for Ortho Dermatologics' Altreno for Acne

Thursday, October 11, 2018 | FDA Approval/Clearance , Phase 3/4 Trials , Acne , Ortho Dermatologics


Ortho Dermatologics shared results of two identical Phase 3, 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. The FDA approved the New Drug Application for Altreno Lotion on Aug. 24, 2018.
Results were publishedd in the Journal of Drugs in Dermatology.
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 (both P<.001) 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.
 
“Extensive clinical data have shown that topical retinoids are highly effective in acne and are recommended as the cornerstone of topical therapy; however, retinoids are perceived to have limited efficacy in inflammatory acne and that tolerability issues are barriers to their use. The results from the two Phase 3 clinical trials demonstrated that Altreno can provide physicians and their patients a new treatment option that significantly reduces inflammatory and noninflammatory acne lesions along with a favorable tolerability profile,” says Sabrina Fabi, MD, a dermatologist and dermatologic cosmetic surgeon from Cosmetic Laser Dermatology, San Diego, and assistant clinical professor, University of California, San Diego.
 
Patient satisfaction was also shown to be significantly greater with Altreno Lotion compared to vehicle, increasing from baseline to week 12 by 53 percent compared to 43 percent with vehicle (P<.001), and with nine out of 10 patients reporting satisfaction with their treatment. Patient satisfaction was measured using the acne-specific quality of life (Acne-QoL) questionnaire. The 19-item Acne-QoL is a validated psychometric instrument designed for use in clinical trials.
 
“Helping to make a difference in the lives of people living with skin conditions, such as acne, is the driving force behind our work at Ortho Dermatologics,” says Bill Humphries, president, Ortho Dermatologics. “We believe these new data further demonstrate the value that ALTRENO Lotion provides patients with acne vulgaris, and we look forward to bringing the product to market by the end of the month.”
 

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