Submental Fat
Conditions
Brief summary
The purpose of this research study is to determine the safety and efficacy of 10XB-101 vs. vehicle (placebo) for adults with excessive submental fat (SMF).
Interventions
One of the three concentrations of 10XB-101 will be evaluated against placebo for submental fat reduction.
DRUG10XB-101 Vehicle Solution for Injection
This is the placebo control
Sponsors
10xBio, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject is a male or non-pregnant female 18 to 65 years old. * Subject has provided written informed consent. * Subject has qualifying Submental Fat evaluation score. * 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 submental area, diffuse SMF, or prominent platysmal bands at rest that may interfere with evaluation of localized fat, in the opinion of the investigator. * Subject has had any prior treatment for SMF (e.g., deoxycholic acid, cryotherapy, liposuction, surgery). * Subject has any medical condition 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinician Submental Fat Scale (CSFS) | 24 weeks after final injection treatment | Change from Baseline after final treatment. CSFS is a 5 point scale, with a higher score indicating higher severity |
| Patient Submental Fat Scale (PSFS) | 24 weeks after final injection treatment | Change from Baseline after final treatment. PSFS is a 5 point scale, with a higher score indicating higher severity |
Countries
United States
Outcome results
None listed