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A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Phase 2b Study of Rzl-012 for Submental Fat Reduction

Sachin Shridharani, MD, FACS, Washington University of St. Louis School of Medicine, St. Louis, Brian Biesman, MD, FACS, Nashville Center for Laser and Facial Surgery, Nashville, TN; Vanderbilt University Medical Center, Nashville, Joel Cohen, MD, AboutSkin Dermatology, Greenwood Village, Glynis Ablon, MD, Ablon Skin Institute and Research Center, Manhattan Beach, CA, Jeanine Downie, MD, Image Dermatology, Montclair, Sabrina Fabi, MD, CL Derm, San Diego, Steve Dayan, MD, DeNova Research, Chicago, IL and Patricia Walker, MD, PhD, Private Practice, Carpinteria, CA
Goals/Purpose: : RZL-012 (5-(3,6-dibromo-9H-carbazol-9-yl)-N,N,N-trimethylpentan-1-aminium chloride) is a novel injectable synthetic molecule that induces adipocytolysis at the injection site followed by a transient inflammatory response and then by tissue remodeling. The objectives of this multicenter, randomized, double-blind, placebo-controlled phase 2b study were to determine the safety and efficacy of high dose and low dose RZL-012 versus placebo on submental fat (SMF) reduction.

Methods/Technique: Male and female subjects (n = 151) aged 18-65 years with excess SMF were enrolled at 12 clinics in the United States. At the baseline visit, subjects were randomized to receive a single treatment session that consisted of multiple injections (32±4) of high dose RZL-012 (average dose of 244mg/subject, n = 50), low dose RZL-012 (average dose of 166mg/subject, n = 53), or placebo (n = 48) into the submental fat bulge. Subjects were followed for safety and efficacy over 84 days. Efficacy was assessed by the Clinician Chin Assessment Tool (C-CAT) and the Subject Chin Assessment Tool (S-CAT), developed by Raziel, as well as by magnetic resonance imaging (MRI).

Results/Complications: The proportion of subjects who had at least a 1-grade improvement on the validated C-CAT and S-CAT on Day 84 versus baseline was significantly higher in the high dose RZL012 versus placebo (78.0% versus 45.8%, p = 0.0010) and low dose RZL-012 versus placebo (67.9% versus 45.8%, p = 0.0249). The difference between the high dose RZL-012 and placebo groups in the number of subjects with at least a 2-point improvement on both the CCAT and S-CAT scales on Day 84 was also statistically significant (34.0% versus 6.3%, p = 0.0007) whereas it was not significant for the low dose RZL-012 versus placebo groups (17.0% versus 6.3%, p = 0.0960). C-CAT and S-CAT scoring were well-correlated with reductions in SMF volume as measured by magnetic resonance imaging. There were no serious adverse events or any clinically significant changes in vital signs or laboratory tests over the course of the study. Local injection site reactions were the most common adverse events, all of which resolved spontaneously, generally in less than 1 week.

Conclusion: A single administration of RZL-012 into SMF was well-tolerated and resulted in dose-dependent significant improvement in SMF appearance as assessed by blinded clinicians and subjects.

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