What side effects are associated with this type of intervention?

Common treatments for double chin that involve fat cell destruction, such as deoxycholic acid (Kybella) and investigational drugs like 10XB-101, often have side effects including swelling, bruising, pain, numbness, redness, and areas of hardness around the treatment area. These side effects are generally temporary but can vary in severity. In rare cases, more serious side effects like difficulty swallowing or nerve injury leading to an uneven smile or facial muscle weakness may occur.

What prior FDA approvals exist?

Kybella (deoxycholic acid) is an FDA-approved injectable treatment for reducing submental fat, commonly known as a double chin. It works by destroying fat cells, which are then naturally eliminated by the body. This treatment is similar to the mechanism likely being studied in the 10XB-101 trial, which also aims to address excessive submental fat through fat cell destruction or inhibition of fat accumulation.

What other types of research exist?

Promising alternatives to 10XB-101 for treating double chin in 2024 include Kybella (deoxycholic acid) injections, which destroy fat cells, and CoolSculpting (cryolipolysis), which freezes and eliminates fat cells. Both are FDA-approved and have shown efficacy in reducing submental fat.

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Other

10XB-101 Injection for Double Chin

Phase 2

Waitlist Available

Research Sponsored by 10xBio, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject is a male or non-pregnant female 18 to 65 years old

Be older than 18 years old

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks after final injection treatment

Summary

This trial is testing a new treatment called 10XB-101. It is aimed at adults who have too much fat under their chin. The treatment works by reducing the fat cells in that area. Researchers want to see if it is safe and effective.

Who is the study for?

This trial is for adults aged 18-65 with a stable body weight and noticeable double chin, who haven't had previous treatments for submental fat. Participants must be willing to receive injections and follow the study plan. Those with loose skin in the area, clotting disorders, or allergies to ingredients in the treatment are excluded.

What is being tested?

The study tests the safety and effectiveness of an injection called 10XB-101 compared to a placebo (vehicle solution) in reducing double chin. The goal is to see if this new treatment can effectively reduce excess fat under the chin.

What are the potential side effects?

While specific side effects aren't listed here, common reactions may include pain at injection site, swelling, bruising, numbness or redness. Allergic reactions could occur in those sensitive to ingredients.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old and not pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have previously undergone treatment for fat under my chin.

Select...

I have a condition that affects my blood's ability to clot.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks after final injection treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks after final injection treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks after final injection treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinician Submental Fat Scale (CSFS)

Patient Submental Fat Scale (PSFS)

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: 10XB-101 Solution for Injection, 4.5%Experimental Treatment1 Intervention

Participants receive 10XB-101 Solution for Injection, 4.5% via subcutaneous injection up to 10 mL. Injection treatment will occur once every 4-6 weeks for up to 6 treatments.

Group II: 10XB-101 Solution for Injection, 3.0%Experimental Treatment1 Intervention

Participants receive 10XB-101 Solution for Injection, 3.0% via subcutaneous injection up to 10 mL. Injection treatment will occur once every 4-6 weeks for up to 6 treatments.

Group III: 10XB-101 Solution for Injection, 2.0%Experimental Treatment1 Intervention

Participants receive 10XB-101 Solution for Injection, 2.0% via subcutaneous injection up to 10 mL. Injection treatment will occur once every 4-6 weeks for up to 6 treatments.

Group IV: 10XB-101 Vehicle Solution for InjectionPlacebo Group1 Intervention

Participants receive 10XB-101 Vehicle Solution for Injection, via subcutaneous injection up to 10 mL. Injection treatment will occur once every 4-6 weeks for up to 6 treatments.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

10XB-101 Solution for Injection

2019

Completed Phase 2

~20

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for double chin, such as those likely studied in the 10XB-101 trial, typically involve mechanisms that target fat cells directly. These treatments may include injectable agents that cause fat cell destruction (lipolysis) or inhibit fat accumulation. For example, deoxycholic acid injections work by breaking down fat cell membranes, leading to cell death and gradual resorption of the fat by the body. This is significant for double chin patients as it provides a non-surgical option to reduce submental fat, improving the contour and appearance of the jawline with minimal downtime and fewer risks compared to surgical procedures.

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