Safety and Efficacy Study of 10XB-101 in Adults With Bilateral Flank Adiposity

Study Overview
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Brief Summary
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The goal of this clinical trial is to test the safety and effectiveness of an injection study drug in decreasing bilateral flank adiposity. The main question it aims to answer is: •How safe and effective is the injection study drug in removing bilateral flank adiposity compared to a placebo? Participants will be: Be given injections every month for 5 months over the right and left flanks. Be asked to be seen in the clinic for 13 visits and 3 phone call visits during a duration of 1 year.

Detailed Description
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Fifteen subjects with bilateral flank adiposity will be enrolled across 1-3 sites in the USA.

Official Title
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A Randomized, Double-Blind, Bilateral Comparison Study of the Safety and Efficacy of 10XB-101 in Adult Subjects With Bilateral Flank Adiposity

Conditions
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Subcutaneous Fat Disorder

Intervention / Treatment
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* Drug: 10XB-101 Solution for Injection, 6.0%
* Drug: Placebo Solution for Injection (no active ingredient)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Active drug 6% vs Placebo
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 10XB-101 Solution for Injection, 6.0%<br>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. | Drug: 10XB-101 Solution for Injection, 6.0%<br>* The active drug (adipolytic) given as subcutaneous injection on either the right or left flank every 4 weeks for 20 weeks.<br>* Other names: 10xB-101, 6%;|
| Placebo Comparator: Placebo Solution for Injection<br>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. | Drug: Placebo Solution for Injection (no active ingredient)<br>* Placebo given as subcutaneous injection on either the right or left flank every 4 weeks for 20 weeks.<br>* Other names: Vehicle solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volumetric measurements | Change from Baseline until end of study. Volumetric measurements will be obtained on each right and left flanks thru a standard photographic assessment. | 24 weeks after final injection treatment | 
| Flank Skin Laxity Scale (FSLS) | Change from Baseline on each flank after final treatment. Flank Skin Laxity Scale (FSLS) is a 4 point scale, with a score of 0 for no skin folds, and a score of 3 for severe or worse skin folds.A higher score means a worse outcome. | 24 weeks after final injection treatment | 
| Clinician Global Impression of Change (CGIC) | Change from Baseline on each flank after final treatment. Clinician Global Impression of Change (CGIC) is a 7-point bi-directional scale with 1 as much improved and 7 as much worse. | 24 weeks after final injection treatment | 
| Patient Global Impression of Change (PGIC) | Change from Baseline on each flank after final treatment. Patient Global Impression of Change (PGIC) is a 7-point bi-directional scale with 1 as much improved and 7 as much worse. | 24 weeks after final injection treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Right and Left Flank Fat