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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks after final injection treatment
Awards & highlights

Study Summary

This trial is testing whether 10XB-101, a treatment for excessive submental fat, 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.Check my eligibility
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.See study design
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
Select...
I am between 18 and 65 years old and not pregnant.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinician Submental Fat Scale (CSFS)
Patient Submental Fat Scale (PSFS)

Side effects data

From 2014 Phase 4 trial • 40 Patients • NCT01602692
40%
Nausea
10%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tumescent Solution With Dilute Epinephrine
Tumescent Solution With Dilute Lidocaine and Epinephrine

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

Find a Location

Who is running the clinical trial?

10xBio, LLCLead Sponsor
2 Previous Clinical Trials
28 Total Patients Enrolled

Media Library

10XB-101 Solution for Injection (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05154955 — Phase 2
Double Chin Research Study Groups: 10XB-101 Solution for Injection, 2.0%, 10XB-101 Vehicle Solution for Injection, 10XB-101 Solution for Injection, 4.5%, 10XB-101 Solution for Injection, 3.0%
Double Chin Clinical Trial 2023: 10XB-101 Solution for Injection Highlights & Side Effects. Trial Name: NCT05154955 — Phase 2
10XB-101 Solution for Injection (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05154955 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I possibly join this study?

"To be eligible for this clinical trial, patients must fall between the ages of 18-65, have submental fat, and meet the following criteria:Subject has had a stable body weight for the past 6 months prior to starting study., Subject has qualifying Submental Fat evaluation score., Subject is a male or non-pregnant female 18 to 65 years old., 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."

Answered by AI

What is the government's stance on 10XB-101 Solution for Injection?

"10XB-101 Solution for Injection is currently in Phase 2 of clinical trials. While there is some safety data, none of it supports efficacy. For this reason, our team has given 10XB-101 a score of 2."

Answered by AI

How many participants are being included in this research?

"That is correct, the information on clinicaltrials.gov currently says that this study is open for enrolment. This trial was first posted on 19th October 2021 and updated most recently on 11th July 2022. There are 4 sites where this trial is taking place and a maximum of 40 people can participate."

Answered by AI

Can people sign up for this research project at this time?

"Yes, the information on clinicaltrials.gov point out that this clinical trial is currently searching for patients. The study was initially posted on 10/19/2021 and was most recently updated on 7/11/2022. The trial is looking for 40 participants at 4 locations"

Answered by AI

Will this research be conducted with geriatric patients?

"The target patient population for this study are those who are young enough to be 18 years old, and not yet 65."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Safety and Tolerability Study of 10XB-101 Injection in Adult Subjects With Submental Fat
2021. "A Safety and Tolerability Study of 10XB-101 Injection in Adult Subjects With Submental Fat". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05154955.
~15 spots leftby May 2025
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