The problem of unwanted submental fat is a fact of life for many individuals. It is unattractive and unappealing aesthetically. The most challenging part of SMF is getting rid of it. The only available options are either highly invasive or lack the necessary scientific evidence and research to validate their usage. One such innovative therapy is ATX-101 (deoxycholic acid). It has been studied to evaluate both the safety of the treatment as well as its efficacy in treating and reducing unwanted body fat. This study was supported by Bayer Healthcare and the results published in the British Journal of Dermatology.
The study analyzed the results from 363 participants who experienced moderate to severe submental fat. It was a placebo controlled, double blind, phase 3 study. The subjects were given ATX-101 or the placebo injections directly into their SMF area, for a maximum of four treatments. They were spaced twenty eight days apart with a follow up session twelve weeks after the last treatment.
The study was designed to analyze:
- Improvement in the SMF on the (CR-SMFRS) the 5 point Clinician Reported Submental Fat Rating Scale.
- The level of patient satisfaction with the appearance of their face and chin using the SSRS (Subject Self Rating Scale).
- Skin Laxity
- Adverse Events
- Caliper measurements
- Patient reported outcomes
- Subjects who received the ATX -101 achieved the desired criteria versus those who received the placebo, up to 65,3% versus 23% for the placebo responders.
- On the SSRS scale a majority of up to 66.1% of those who received the ATX-101 therapy reported that they were satisfied with the appearance of their face and chin.
- Measurements taken using the calliper show significant reductions in SMF.
- Despite the reduction in SMF the laxity of the skin was not worsened by the treatment.
- Patient reported outcomes show that they experienced improvements in the severity as well as the psychological impact of SMF using ATX-101 versus the who received the placebo.
- Adverse events reported were temporary and associated with the injection site.
The conclusion of the study done was that ATX-101 was well tolerated by individuals and is an effective and valid non surgical option for the reduction of unwanted submental fat.