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.
About 15 subjects with excessive submental fat (SMF) will be enrolled across 2 sites in the United States.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Active test article
Site 01
San Diego, California, United States
Adverse Events
Incidence (severity and causality) of any local and systemic Adverse Events
Time frame: 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
Time frame: 24 weeks
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
Time frame: 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
Time frame: 24 weeks
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