Skin laxity and fat build-up 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 presented at the Annual Meeting of the American Society for Aesthetic Plastic Surgery (ASAPS) shows the potential of a novel injectable drug for submental fat reduction. Steven H. Dayan, MD who practices in Chicago, IL, presented the latest data from clinical trials of ATX-101.
‘An unfavourable 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.’
Phase III trials
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% 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 versus 20.5% in placebo (P<0.001).
After two treatments, 52.2% of subjects achieved at least a one grade change from baseline in the clinician submental fat ratings, and 71.5% after four treatments.
Response to ATX-101 was consistent across demographic and baseline subgroups with approximately 80% 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 non-invasive injection might offer patients the treatment option they’ve been desiring.’
Adverse effects mild
The pooled analysis also found that 80.9% of ATX-101 treatment-emergent adverse events were mild and 1.4% of ATX-101 subjects discontinued the studies owing to adverse events. The most common adverse events observed 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, randomised, placebo-controlled clinical trials being conducted in the US and Canada with over 2500 participants who have moderate-to-severe submental fat.