April 2020 HSC Section 4 - Plastic and Reconstructive Problems

Reprinted by permission of Dermatol Surg. 2019; 45(12):1531-1541.

A Double-Blind, Placebo-Controlled, Phase 3b Study of ATX-101 for Reduction of Mild or Extreme Submental Fat Richard G. Glogau, MD,* † Dee Anna Glaser, MD, ‡ Valerie D. Callender, MD, x Steve Yoelin, MD, ║ Jeffrey S. Dover, MD, ¶ Jeremy B. Green, MD, # Laura Breshears, PhD,** and Beta Bowen, MS ††

BACKGROUND ATX-101 (deoxycholic acid injection) is approved for reduction of moderate or severe submental fat (SMF).

OBJECTIVE To evaluate the efficacy and safety of ATX-101 in subjects with mild or extreme SMF.

PATIENTS AND METHODS Adults with mild or extreme SMF (based on clinician assessment) were randomized to receive # 6 treatments with ATX-101 or placebo. Efficacy end points, evaluated at 12 weeks after last treatment, included percentage of subjects who achieved $ 1-grade improvement in SMF from baseline based on both clinician and patient assessment (composite CR-1/PR-1 response) as well as multiple subject-reported outcomes. Safety end points included change in skin laxity and incidence of adverse events. RESULTS Overall, 61.3% of ATX-101–treated subjects versus 6.7% of placebo-treated subjects with mild SMF and 89.3% versus 13.3% of subjects, respectively, with extreme SMF achieved a composite CR-1/PR-1 response ( p < .001 for both). ATX-101–treated subjects also reported higher levels of satisfaction and greater reductions in the psychological impact of SMF versus placebo-treated subjects regardless of baseline SMF severity. Skin laxity was unchanged or improved in most of the subjects. Adverse events were mainly mild/moderate, transient, and associated with the injection site. R. Glogau received payment as an investigator for this clinical trial. D.A. Glaser received payment as an investigator for this clinical trial and previously received grants, consulting fees, travel support, and payment for development of education materials from Kythera Biopharmaceuticals, Inc. V.D. Callender received pay- ment as an investigator for this clinical trial and receives grants and consulting fees from Allergan. S. Yoelin received payment as an investigator for this clinical trial and receives grants, consulting fees, travel support, and payment for development of education materials and lectures (including service on speakers bureaus) from Allergan. J.S. Dover received payment as an investigator for this clinical trial and previously received grants from and was a paid board member for Kythera Biopharmaceuticals, Inc. J.B. Green received payment as an investigator for this clinical trial and receives grants, consulting fees, and payment for lectures (including service on speakers’ bureaus) from Allergan. L. Breshears was an employee and stockholder with Evidence Scientific, Inc., at the time the manuscript was written. B. Bowen is an employee of Allergan plc. CONCLUSION ATX-101 was efficacious and well tolerated for reduction of mild or extreme SMF.

T he presence of submental fat (SMF) may be associated with dissatisfaction with one ’ s appearance and increased psychological distress, particularly because submental convexity can

cause one to appear overweight and/or older. 1 Although SMF can sometimes be due to obesity or weight gain, it often remains after weight loss because genetics and age also play a role. 1 – 3

*Department of Dermatology, University of California San Francisco, San Francisco, California; † Private Practice, San Francisco, California; ‡ Department of Dermatology, Saint Louis University, St. Louis, Missouri; x Department of Dermatology, Howard University College of Medicine, Washington, DC; ║ Ophthalmology Division, Medical Associates, Inc., Newport Beach, California; ¶ Dermatology Division, SkinCare Physicians, Chestnut Hill, Massachusetts; # Dermatology Division, Skin Associates of South Florida, Coral Gables, Florida; **Evidence Scienti fi c Solutions, Philadelphia, Pennsylvania; †† Allergan plc, Irvine, California © 2019 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved. ISSN: 1076-0512 · Dermatol Surg 2019;00:1 – 11 · DOI: 10.1097/DSS.0000000000001850

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