10xBio Completes Enrollment of Phase 2b Trial of Novel Drug for Submental Body Contouring

10xBio completed enrollment in a repeat treatment study of its novel injectable drug for submental body contouring. 

The drug, 10XB101, is a proprietary formulation of polidocanol, which is approved in the U.S. for vein sclerotherapy. 

"I have been involved in the study of polidocanol for vein sclerotherapy for more than 40 years and am proud to lead the scientific and clinical effort to study this novel formulation of it for a new indication," says Mitchel P. Goldman, M.D., a dermatologic surgeon and medical director of Platinum and West Dermatology in Newport Beach, Calif. "I believe that 10XB101 can achieve superior efficacy and tolerability than the currently marketed body contouring drug, deoxycholate, which I have more than 10 years of experience with. I look forward to seeing the results of this trial."

A total of 51 patients are enrolled in this randomized, double-blind study across three treatment groups, including a placebo control group. Patients will receive multiple injections of 10XB101 in a predefined pattern and can receive multiple treatments spaced one month apart. Efficacy will be assessed with a physician and patient submental fullness rating scale, measured 12 weeks after the patient's final treatment. Tolerability will be assessed by recording local skin reactions on a four-point ordinal scale, including edema/swelling, pain, bruising, tenderness on palpation and erythema. The study is expected to be completed by the end of 2023.

In a previous study, 10XB101 showed excellent tolerability with minimal pain, swelling, bruising, and erythema. Patients and physicians reported improvements in a submental fullness rating scale after a single treatment.