FightAcne.com: What are the main findings?
Response:In two pooled phase 3 studies, tazarotene 0.045% lotion demonstrated efficacy in the treatment of moderate-to-severe acne in both Black and White participants. After once-daily treatment for 12 weeks, both groups had over a 52% reduction in inflammatory and noninflammatory acne lesions. Further, nearly one-third of Black and White participants achieved treatment success, which was defined as clear/almost clear skin and a reduction of at least 2 points on the Evaluator’s Global Severity Score scale. In Black participants, high baseline rates of hyperpigmentation were reduced with tazarotene lotion at week 12 but did not change with vehicle lotion.
FightAcne.com:What should readers take away from your report?
Response: This analysis of patients who self-identified as Black or White shows that tazarotene 0.045% lotion is an effective and well tolerated treatment option for many types of patients with acne, including those with skin of color. Additionally, there were no differences in the improvement of acne and rates of side effects between Black and White participants. In Black participants, tazarotene 0.045% lotion led to improvements in hyperpigmentation, which is an inflammation-related complication of acne that more frequently occurs in patients with skin of color.
FightAcne.com: What recommendations do you have for future research as a result of this study?
Response: Many clinical studies of acne enroll very few patients of color, which limits data we have in this population. But there are racial and ethnic differences in clinical presentation of acne and inflammation-related complications such as hyperpigmentation. The relatively high number of Black patients in our studies allowed us to analyze the efficacy and safety of tazarotene 0.045% lotion in participants with skin of color. Future clinical trials should work to enroll more patients with a variety of skin types from different racial and ethnic backgrounds to best understand how drugs works in different patient populations.
FightAcne.com:Is there anything else you would like to add? Any disclosures?
Response: Thank you for the opportunity to discuss our recent clinical trial results. I have served as a consultant, speaker, and/or investigator for Galderma, LEO Pharma, Almirall, Cassiopea, Ortho Dermatologics, Pfizer, Arcutis, Encore, Foamix, Hovione, Regeneron, Aclaris, and Cutanea.
Citation: Fall 2020 Clinical Dermatology Conference abstract:
Title: Novel Polymeric Tazarotene 0.045% Lotion for Moderate-to-Severe Acne: Pooled Phase 3 Analysis by Race
Authors: Fran E Cook-Bolden, MD1; Neal Bhatia, MD2; Jonathan S Weiss, MD3; Neil Sadick, MD4; Stephen K Tyring, MD, PhD5; Eric Guenin, PharmD, PhD, MPH6; Anya Loncaric, MS7; Susan Harris, MS8
1Fran E. Cook-Bolden, MD, PLLC and Department of Dermatology, Mount Sinai Hospital Center, New York, NY; 2Therapeutics Clinical Research, San Diego, CA; 3Georgia Dermatology Partners, and Gwinnett Clinical Research Center, Inc., Snellville, GA; 4Department of Dermatology, Weill Cornell Medical College, New York, NY and Sadick Dermatology, New York, NY; 5University of Texas Health Science Center, Houston, TX; 6Ortho Dermatologics,* Bridgewater, NJ; 7Bausch Health US, LLC,* Petaluma, CA; 8Bausch Health US, LLC,* Bridgewater, NJ
*Bausch Health US, LLC is an affiliate of Bausch Health Companies Inc. Ortho Dermatologics is a division of Bausch Health US, LLC.
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