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Clinical trial

A Multi-Center, Randomized, Double-Blinded, Vehicle-Controlled Study of the Safety and Efficacy of 10XB-101 in Adult Subjects With Submental Fat

ID
Name
210-9451-203
Description
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).
Trial arms
Trial start
2021-10-19
Estimated PCD
2024-05-01
Trial end
2024-05-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
10XB-101 Solution for Injection
One of the three concentrations of 10XB-101 will be evaluated against placebo for submental fat reduction.
Arms:
10XB-101 Solution for Injection, 2.0%, 10XB-101 Solution for Injection, 3.0%, 10XB-101 Solution for Injection, 4.5%
10XB-101 Vehicle Solution for Injection
This is the placebo control
Arms:
10XB-101 Vehicle Solution for Injection
Size
52
Primary endpoint
Clinician Submental Fat Scale (CSFS)
24 weeks after final injection treatment
Patient Submental Fat Scale (PSFS)
24 weeks after final injection treatment
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 52, 'type': 'ESTIMATED'}}
Updated at
2023-07-12

1 organization

1 product

1 indication

Organization
10xBio
Product
10XB-101
Indication
Submental fat