10xBio has announced the completed enrollment for a repeat treatment study of its novel injectable drug for submental body contouring, 10XB101, a proprietary formulation of polidocanol, which is approved in the U.S. for vein sclerotherapy. 10xBio is repurposing polidocanol for body contouring applications in aesthetic medicine. 10XB101 is an alternative to body contouring devices, potentially offering benefits like enhanced patient tolerability, shorter treatment intervals and more.
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A total of 51 patients will participate in the 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 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.
"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," said Mitchel P. Goldman, M.D., a dermatologic surgeon and medical director of Platinum and West Dermatology. "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."
