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10XB-101 Solution for Injection 1.25% 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights

Study Summary

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse Events
Local Skin Reactions (LSR)
Secondary outcome measures
Clinician Submental Fat Scale (CSFS)
Patient Submental Fat Scale (PSFS)

Side effects data

From 2014 Phase 4 trial • 106 Patients • NCT02054325
51%
Hyperpigmentation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Polidocanol With Glucose
Glucose

Trial Design

5Treatment groups
Experimental Treatment
Group I: 10XB-101 Solution for Injection 6.0%Experimental Treatment1 Intervention
Participants receive 10XB-101 Solution for Injection, 6.0% via subcutaneous injection up to 10 mL on Day 1 of subject participation.
Group II: 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 on Day 1 of subject participation.
Group III: 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 on Day 1 of subject participation.
Group IV: 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 on Day 1 of subject participation.
Group V: 10XB-101 Solution for Injection 1.25%Experimental Treatment1 Intervention
Participants receive 10XB-101 Solution for Injection, 1.25% via subcutaneous injection up to 10 mL on Day 1 of subject participation.
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
65 Total Patients Enrolled
John Dobak, MDStudy Director10xBio, LLC

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Safety and Tolerability Study of 10XB-101 Injections in Adult Subjects With Extra Fat Under the Chin ("Double Chin")
2019. "A Safety and Tolerability Study of 10XB-101 Injections in Adult Subjects With Extra Fat Under the Chin ("Double Chin")". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04258761.
~3 spots leftby Apr 2025
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