drugset / Trial / NCT01546142
Phase 3 Study of Deoxycholic Acid Injection (ATX-101) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area
RandomizedParallel-groupDouble-blindTreatment
Summary
To evaluate the safety and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin).
Timeline
- Start
- 2012-03
- Primary completion
- 2013-05
- Completion
- 2013-08
Outcome
Met primary endpoint
registry Deoxycholic Acid Injection vs Placebo; p <0.001; Risk Ratio (RR) 2.983 (95% CI 2.311 to 3.849); Cochran-Mantel-Haenszel NCT01546142 ↗
registry NUMBER Deoxycholic Acid Injection: 66.5 percentage of participants NUMBER Placebo: 22.2 percentage of participants NCT01546142 ↗
registry Deoxycholic Acid Injection vs Placebo; p <0.001; Risk Ratio (RR) 6.271 (95% CI 2.908 to 13.520); Cochran-Mantel-Haenszel NCT01546142 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Deoxycholic Acid | Unknown | 2 unknown | — |
Indications
No indication recorded.