Safety Study of ATX-101 in Subjects With Varying Chin Sizes
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | December 2013 |
| End Date: | June 2015 |
A Multicenter, Double-blind, Placebo-controlled Safety Study of ATX-101 (Deoxycholic Acid Injection) for the Reduction of Localized Subcutaneous Fat in the Submental Area in Subjects With Clinician-Reported Submental Fat Rating Scale (CR SMFRS) Grade 1 or CR-SMFRS Grade 4
The objectives of this study are to explore the safety and efficacy of subcutaneous
injections of ATX-101 relative to placebo, in the submental area.
injections of ATX-101 relative to placebo, in the submental area.
Inclusion Criteria:
- Male and female subjects, 18 to 65 years old
- Stable Body weight
- BMI of ≤40.0 kg/m2
- Acceptable volume of submental fat graded by clinician
- Dissatisfaction with the submental area expressed by the subject
- Signed informed consent form (ICF)
Exclusion Criteria:
- No prior intervention for SMF (eg, liposuction, surgery, or lipolytic agents)
- Absence of clinically significant health problems
- History of any intervention to treat SMF (eg, liposuction, surgery, or lipolytic
agents)
- History of trauma associated with the chin or neck areas that in the judgment of the
investigator may affect evaluation of safety or efficacy of treatment
- Body mass index ≤40 kg/m2
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