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OpenTrials
Completed

NCT Number: NCT04258761

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

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.

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Key information

Conditions

Submental Fat

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site 01

San Diego, California, 92123, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

10XB-101 Solution for Injection

Drug

Active test article

Other names: polidocanol

Primary outcomes

  1. Adverse Events

    Time frame: 24 weeks

    Incidence (severity and causality) of any local and systemic Adverse Events

  2. Local Skin Reactions (LSR)

    Time frame: 24 weeks

    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

Secondary outcomes

  1. Clinician Submental Fat Scale (CSFS)

    Time frame: 24 weeks

    Change from Baseline in the CSFS on a five-point scale (zero to 4), with a higher score indicating a worse outcome

  2. Patient Submental Fat Scale (PSFS)

    Time frame: 24 weeks

    Change from Baseline in the PSFS on a five-point scale (zero to 4), with a higher score indicating a worse outcome

Sponsors and collaborators

Lead sponsor

10xBio, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Feb 6, 2020
Registry last updated
Apr 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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