A Safety and Tolerability Study of 10XB-101 Injection in Adult Subjects With Submental Fat

Submental Fat Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05154955
• Other study ID #: 210-9451-203
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: October 19, 2021
• Est. completion date: May 2024

Study information

• Verified date: July 2023
• Source: 10xBio, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 52
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Submental Fat

Intervention

Drug:
• 10XB-101 Solution for Injection
One of the three concentrations of 10XB-101 will be evaluated against placebo for submental fat reduction.
• 10XB-101 Vehicle Solution for Injection
This is the placebo control

Locations

Country	Name	City	State
United States	Site 03	Encino	California
United States	Site 04	Rolling Meadows	Illinois
United States	Site 01	San Diego	California
United States	Site 02	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
10xBio, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician Submental Fat Scale (CSFS)	Change from Baseline after final treatment. CSFS is a 5 point scale, with a higher score indicating higher severity	24 weeks after final injection treatment
Primary	Patient Submental Fat Scale (PSFS)	Change from Baseline after final treatment. PSFS is a 5 point scale, with a higher score indicating higher severity	24 weeks after final injection treatment