Skin laxity and fat buildup under the chin is a common concern among facial aesthetic patients. Although surgery has long been the mainstay for reducing fat in this area, which is also known as the submental region, new research being presented at the Annual Meeting of the American Society for Aesthetic Plastic Surgery (ASAPS) being held April 24 – 29, 2014 in San Francisco, CA, shows the potential of a novel injectable drug for submental fat reduction. Steven H. Dayan, MD who practices in Chicago, IL, will present the latest data from clinical trials of a new, investigational injectable drug, ATX-101, during “ATX-101, A Submental Contouring Injectable Drug for the Reduction of Submental Fat” on Saturday, April 26th.
“An unfavorable profile can make people look older and heavier, negatively affect self-esteem, and cannot usually be significantly altered by diet or exercise,” said Dr. Dayan. “We are excited to present trial results on this potential first-in-class submental contouring injectable, which, if approved, could offer physicians and their patients a non-surgical option to eliminate fat under the chin, resulting in a thinner and more contoured profile and jawline.”
Dr. Dayan is presenting the first disclosure of a pooled analysis of two positive ATX-101 Phase III trials (REFINE-1 and REFINE-2) evaluating the reduction of submental fat. Results of the pooled analysis, conducted by KYTHERA Biopharmaceuticals, found that:
- 68.2 percent of ATX-101 (2 mg/cm2) subjects demonstrated a simultaneous improvement of at least one grade from baseline on clinician and patient reported rating scales vs. 20.5 percent in placebo (p<0.001).
- After two treatments, 52.2 percent of subjects achieved at least a one grade change from baseline in the clinician submental fat ratings, and 71.5 percent after four treatments.
- Response to ATX-101 was consistent across demographic and baseline subgroups with approximately 80 percent of subjects treated with ATX-101 demonstrating at least a one grade improvement in the clinician submental fat ratings regardless of age, gender, race, BMI, Fitzpatrick Skin Type and baseline severity.
- ?? Those treated with ATX-101 reported significant improvement in the visual and emotional impact of chin fat, including appearing thinner and more youthful, compared with those treated with placebo (p<0.001).
“Eliminating fat in the submental region not only plays a critical role in helping restore overall facial balance and harmony, but can also lead to vast improvements in self-perception as well as the first impression projected,” said Dr. Dayan. “We are looking forward to sharing our findings, which show how a noninvasive injection might offer patients the treatment option they’ve been desiring.” The pooled analysis also found that 80.9 percent of ATX-101 treatment-emergent adverse events were mild and 1.4 percent of ATX-101 subjects discontinued the studies due to adverse events. The most common adverse events observed in the clinical trials included temporary injection site events of pain, swelling, bruising and numbness. The incidence and severity of pain and swelling declined after the first treatment session.
ATX-101 is a proprietary formulation of a purified synthetic version of a naturally occurring molecule (deoxycholic acid) that aids in the breakdown of dietary fat. It is currently in late stage clinical trials for the reduction of submental fat, which commonly presents as a double chin. When injected into subcutaneous fat, ATX-101 contours the area under the chin by destroying fat cells while leaving surrounding tissue largely unaffected. It has been evaluated in double-blind, randomized, placebo- controlled clinical trials being conducted in the US and Canada with over 2,500 participants who have moderate-to-severe submental fat. Detailed data from a pooled analysis will be revealed during Saturday’s presentation.
ATX-101, A Submental Contouring Injectable Drug for the Reduction of Submental Fat: A Pooled Analysis of Two Pivotal Phase 3 (REFINE-1 and REFINE-2) Multicenter, Double-Blind, Randomized, Placebo-Controlled Trials, Steven H. Dayan, MD, Derek H. Jones, MD, Jean Carruthers, MD, FRCS(c), Shannon Humphrey, MD, Fredric S. Brandt, MD, Patricia Walker, MD, PhD, Daniel Lee, MS, Paul F. Lizzul, MD, PhD, Frederick C. Beddingfield III, MD, PhD