Safety and Efficacy Study of 10XB-101 in Adults With Bilateral Flank Adiposity
Subcutaneous Fat Disorder
About this trial
This is an interventional treatment trial for Subcutaneous Fat Disorder focused on measuring Right and Left Flank Fat
Eligibility Criteria
Inclusion Criteria: Subject is a male or non-pregnant female 18 to 55 years old. Subject has provided written informed consent. Subject has qualifying fat evaluation and skin laxity scores on each right and left flanks. Subject has had a stable body weight for the past 6 months prior to starting study. Subject is willing to undergo test article injections as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study. Exclusion Criteria: Subject is pregnant, lactating, or is planning to become pregnant during the study. Subject has loose skin in the right and left flank areas, unrepaired abdominal injury or defect, scars, tattoos, or other features that may interfere with evaluation of localized fat, in the opinion of the investigator. Subject has any medical condition or taking medications that affects clotting and/or platelet function Subject has a history of allergy or sensitivity to polidocanol or any of the other ingredients in the test articles.
Sites / Locations
- Site #01Recruiting
- Site #02Recruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
10XB-101 Solution for Injection, 6.0%
Placebo Solution for Injection
Participants receive 10XB-101 Solution for Injection, 6.0% via subcutaneous injection up to 10 mL. Injection treatment will occur once every 4 weeks for up to 6 treatments.
Participants receive Placebo Solution for Injection, via subcutaneous injection up to 10 mL. Injection treatment will occur once every 4 weeks for up to 6 treatments.