Bausch Health Announces Publication Of Pivotal Phase 3 Efficacy And Safety Data On ALTRENO™ (tretinoin) Lotion, 0.05% In The Journal Of Drugs In Dermatology
Published: Oct 11, 2018
ALTRENO Lotion Provides Statistically Significant Greater Efficacy Over Vehicle with a Favorable Safety and Tolerability Profile in Two Pivotal Clinical Trials1
LAVAL, Quebec, Oct. 11, 2018 /PRNewswire/ -- 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 has published results of two identical Phase 3, multicenter, randomized, double-blind, vehicle-controlled, parallel group studies examining the efficacy and safety of ALTRENOTM (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.1 The U.S. Food and Drug Administration approved the New Drug Application for ALTRENO Lotion on Aug. 24, 2018.
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.1
"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," said Sabrina Fabi, M.D., 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.1
"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," said 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."
About the Phase 3 Studies
Patients were randomized 1:1 to receive ALTRENO Lotion or vehicle once-daily for 12 weeks, with assessments carried out at four, eight and 12 weeks of treatment. The primary efficacy endpoint was the absolute change from baseline to week 12 in mean inflammatory and noninflammatory lesion counts, and the proportion of patients who were clear to almost clear achieved at least a two-grade reduction from baseline to week 12 in EGSS. Secondary efficacy endpoints included mean percent change from baseline to week 12 in inflammatory and noninflammatory lesion counts and the proportion of patients who achieved at least a two-grade reduction from baseline.1
Additional assessments included a patient satisfaction score (PSS) assessment, a validated acne-specific quality of life (Acne-QoL) questionnaire and an assessment of degree of shininess/oiliness of facial skin and its range of bothersomeness. Safety adverse events, which were summarized by treatment group, severity, and relationship to study medication, were evaluated throughout.1
IMPORTANT SAFETY INFORMATION FOR ALTRENO™ (TRETINOIN), 0.05% LOTION
What is Altreno™?
Important Safety Information
Before you use ALTRENO, tell your healthcare provider about all your medical conditions, including if you:
- are allergic to fish. ALTRENO contains fish proteins. Tell your healthcare provider if you get hives or itching during treatment with ALTRENO.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain medicines, vitamins, or supplements may make your skin more sensitive to sunlight. Also, tell your healthcare provider about any cosmetics you use, including moisturizers, creams, lotions, or products that can dry out your skin.
What should I avoid while using ALTRENO?
What are the possible side effects of ALTRENO?
ALTRENO may have serious side effects, including skin irritation. ALTRENO may cause irritation including skin dryness, pain, redness, excessive flaking or peeling. If you develop these symptoms, your healthcare provider may tell you to stop using ALTRENO for a while, decrease how often you use it, or stop it altogether. Avoid applying ALTRENO to skin that is affected by eczema or sunburned skin.
You may report side effects to the FDA at 1-800-FDA-1088.
Please click here for full Prescribing Information.
About Acne Vulgaris
About Ortho Dermatologics
About Bausch Health
ALTRENO is a trademark of Ortho Dermatologics' affiliated entities.
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SOURCE Bausch Health Companies Inc.
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