ASDS abstract session shows clinical benefits of Kybella for treating submental fat

CHICAGO — Studies focusing on different aspects of Kybella treatment for submental fat and its results were the focus of morning abstract sessions at the American Society for Dermatologic Surgery Annual Meeting.

Four of 10 abstracts presented were based on trials of Kybella (deoxycholic acid, Allergan), also known as ATX-101, which was approved by the FDA earlier this year for treatment of moderate- to-severe submental fullness.

“There was a lot of … in-depth [information] about ATX-101, which we call Kybella clinically,” session moderator Wendy E. Roberts, MD, told Healio.com. “It addresses skin laxity, so there is a tightening effect that’s seen with Kybella; it’s safe, [with] minimal adverse events, all of which are transient.”

Pearls shared by the researchers included the use of an anesthetic, which was not used in the studies, but the speakers felt that the inclusion of an anesthetic, either lidocaine or marcaine, pre-procedurally reduced the amount of pain and discomfort, Roberts said.

A study highlight was with a group of patients with mild submental fullness, who were not addressed in initial clinical studies, but who also showed improvement after treatment. “It shows that there is efficacy in early treatment of submental fullness,” Roberts said.

The abstracts focusing on Kybella and submental fullness included:

The Conditions of Submental Fullness and Treatment Outcomes Registry (CONTOUR); A Non-Interventional Study of Submental Fullness, Treatment Options Administered and Associated Outcomes, presented by Kenneth R. Beer, MD;
Changes in Skin Laxity Among Responder to Deoxycholic Acid Injection in the REFINE trials, presented by Sabrina G. Fabi, MD;
Reductions in Submental Fat Achieved with Deoxycholic Acid Injection are Maintained Over Time: Results from Long-term, Follow-up Studies, presented by Ashish Bhatia, MD; and
A Double-blind, Placebo-controlled, Phase 3b Safety Study of Deoxycholic Acid Injection for Reduction of Submental Fat in Subjects with Mild or Extreme Submental Fullness, which was awarded the top prize for oral abstracts at the ASDS meeting.

“The main point of the study is it expanded the range of patients for whom treatment with Kybella is appropriate,” presenter and researcher Richard G. Glogau, MD, told Healio.com. “The registration trials were all done with moderate-to-severe [patients], and what we did was look at patients that had very mild submental fat and very extreme submental fat.

“It has the same adverse effect on safety profile as the moderate-to-severe group in the registration trials. It was reassuring to know that we can use [deoxycholic acid] in anybody who is interested in treating that area.” – by Bruce Thiel

Reference:

OA306 Morning Joe: Caffeinated Oral Abstact Presentations. Presented at: ASDS Annual Meeting; Oct. 15-18, 2015; Chicago.