Safety Study of ATX-101 for the Reduction of Localized Subcutaneous Fat in the Submental Area in Subjects 65 to 75 Years of Age
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 65 - 75 |
| Updated: | 4/21/2016 |
| Start Date: | April 2014 |
| End Date: | September 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 65 to 75 Years of Age
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 of subjects who are 65 to
75 years old.
injections of ATX-101 relative to placebo, in the submental area of subjects who are 65 to
75 years old.
Inclusion Criteria:
- Males and females, 65 to 75 years of age
- Stable Body Weight
- Dissatisfaction with the submental area expressed by subject
- Acceptable volume of submental fat graded by clinician
- BMI of ≤40.0 kg/m2
- Signed informed consent (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)
- Anatomical features for which reduction in SMF may result in aesthetically
unacceptable outcome, judged by clinician
- History of trauma associated with the chin or neck areas that in the judgment of the
investigator may affect evaluation of safety or efficacy
- Body mass index of ≤ 40.0 kg/m2
We found this trial at
6
sites
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