A Safety and Tolerability Study of 10XB-101 Injections in Adult Subjects With Extra Fat Under the Chin ("Double Chin")

A Multi-Center, Open Label, Single Ascending Dose Safety and Tolerability Study of Subcutaneously Administered 10XB-101 in Adult Subjects With Excessive Submental Fat

The purpose of this research study is to find out more about an investigational drug, 10XB-101, for people with fat under their chin which they would like to remove. The Sponsor of this study thinks there may be a chance this drug could be used to dissolve, or "melt" this fat away.

Study Overview

• Status: Completed
• Conditions: Submental Fat
• Intervention / Treatment: Drug: 10XB-101 Solution for Injection

Detailed Description

About 15 subjects with excessive submental fat (SMF) will be enrolled across 2 sites in the United States.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Site 01

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subject is a male or non-pregnant female 18-65 years of age
• Signed informed consent
• Subject has a score of 2 or 3 on the Clinician Submental Fat Scale (CSFS) at Visit 2/Baseline
• Subject is in good general health

Exclusion Criteria:

• Loose skin or prominent platysmal bands in the neck or chin area
• Recent treatment with anticoagulants
• Presence of clinically significant health problems

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 10XB-101 Solution for Injection 1.25%; Participants receive 10XB-101 Solution for Injection, 1.25% via subcutaneous injection up to 10 mL on Day 1 of subject participation.	Drug: 10XB-101 Solution for Injection; Active test article; Other Names: polidocanol
Experimental: 10XB-101 Solution for Injection 2.0%; Participants receive 10XB-101 Solution for Injection, 2.0% via subcutaneous injection up to 10 mL on Day 1 of subject participation.	Drug: 10XB-101 Solution for Injection; Active test article; Other Names: polidocanol
Experimental: 10XB-101 Solution for Injection 3.0%; Participants receive 10XB-101 Solution for Injection, 3.0% via subcutaneous injection up to 10 mL on Day 1 of subject participation.	Drug: 10XB-101 Solution for Injection; Active test article; Other Names: polidocanol
Experimental: 10XB-101 Solution for Injection 4.5%; Participants receive 10XB-101 Solution for Injection, 4.5% via subcutaneous injection up to 10 mL on Day 1 of subject participation.	Drug: 10XB-101 Solution for Injection; Active test article; Other Names: polidocanol
Experimental: 10XB-101 Solution for Injection 6.0%; Participants receive 10XB-101 Solution for Injection, 6.0% via subcutaneous injection up to 10 mL on Day 1 of subject participation.	Drug: 10XB-101 Solution for Injection; Active test article; Other Names: polidocanol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Incidence (severity and causality) of any local and systemic Adverse Events	24 weeks
Local Skin Reactions (LSR)	At each time point, the number of subjects with presence (and severity) of the following LSRs on a 4 point scale (zero to 3), with a higher score indicating a worse outcome: erythema, edema, tenderness on palpation, bruising, pain, and stinging/burning	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinician Submental Fat Scale (CSFS)	Change from Baseline in the CSFS on a five-point scale (zero to 4), with a higher score indicating a worse outcome	24 weeks
Patient Submental Fat Scale (PSFS)	Change from Baseline in the PSFS on a five-point scale (zero to 4), with a higher score indicating a worse outcome	24 weeks

Collaborators and Investigators

• Sponsor: 10xBio, LLC
• Investigators: Study Director: John Dobak, MD, 10xBio, LLC

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2019
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: January 27, 2020
• First Submitted That Met QC Criteria: February 4, 2020
• First Posted (Actual): February 6, 2020

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pharmaceutical Solutions; Sclerosing Solutions; Polidocanol
• Other Study ID Numbers: 210-9451-202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No