MIAMI BEACH – ATX-101, an investigational injectable deoxycholic acid, is safe and effective for the non-surgical reduction of submental fat, according to interim findings from a 12-month phase IIIb open-label study.
At 3-month follow-up after their last treatment, 87% and 83% of 165 study participants achieved at least a 1-point improvement on the clinician and patient submental fat rating scales, respectively, Dr. Susan Weinkle reported during a late-breaking abstract session at the annual meeting of the American Academy of Dermatology.
"That is major," Dr. Weinkle, a dermatologist in private practice in Bradenton, Fla., said of the patients’ rating scale scores.
Dr. Susan H. Weinkle
Patients reported feeling less bothered by, and self-conscious about, their submental fat, and they also reported feeling younger. Most – about 96% – experienced unchanged or improved skin laxity in the treated area.
"Many, despite the fact that their body mass index stayed the same, actually felt like they looked like they had lost weight ... let me tell you, they were very, very happy," she said.
In fact, 94% reported being happy they had the procedure.
The study participants were men and women of varying ages, races, and Fitzpatrick skin types, who were dissatisfied with their appearance associated with the chin region. All had submental fat scale scores of 2 to 4 on both clinician and patient rating scales, had stable weight, and had received no prior treatments to the submental fat region. They received up to 6 treatments, at 4-week intervals, with ATX-101 at a dosage of 2 mg/cm2. Injections were administered with a 30-gauge needle, and "little microinjections at 2 mm areas across the submental region," Dr. Weinkle said, noting that the number of injections was tailored as the fat decreased over time.
Treatments were provided at 21 sites across the United States.
Treatment-related adverse events occurred in more than 91% of patients, but these were mainly mild-to-moderate injection site hematomas, numbness, pain, edema, and erythema – and all were transient, she said
No changes in blood lipids occurred.
This "really exciting research" suggests that ATX-101, a synthetically derived product that has been shown to destroy and eliminate fat through adipocytolysis, "may very well provide, in the future, an approach to submental fat for our patients who are so unhappy with this part of their body," she said.
"This is an important thing to people, and it makes a huge difference ... if [ATX-101] has the opportunity to come to market, it will make a big impact for our patients," she added.
To date, between 2,000 and 3,000 patients have been studied, including 1,500 who have received active treatment, and 1,500 who received placebo. Patients in the current study will be followed out to 12 months, she said.
This study was funded by Kythera. Dr. Weinkle disclosed that she worked with Kythera as an investigator for the study.