Evaluation of Safety and Efficacy of Deoxycholic Acid Injection (ATX-101) in the Reduction of Submental Fat
Summary
To evaluate the safety and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin).
Timeline
- Start
- 2011-01
- Primary completion
- 2012-02
- Completion
- 2012-02
Outcome
Met primary endpoint
registry analysis (superiority or other test); Deoxycholic Acid Injection 1 mg/cm² vs Placebo; p <0.001; Odds Ratio (OR) 2.60 (95% CI 1.52 to 4.43); Regression, Logistic NCT01294644 ↗
registry analysis (superiority or other test); Deoxycholic Acid Injection 2 mg/cm² vs Placebo; p <0.001; Odds Ratio (OR) 3.13 (95% CI 1.83 to 5.36); Regression, Logistic NCT01294644 ↗
registry analysis (superiority or other test); Deoxycholic Acid Injection 1 mg/cm² vs Placebo; p <0.001; Odds Ratio (OR) 5.37 (95% CI 3.06 to 9.44); Regression, Logistic NCT01294644 ↗
registry analysis (superiority or other test); Deoxycholic Acid Injection 2 mg/cm² vs Placebo; p <0.001; Odds Ratio (OR) 4.62 (95% CI 2.65 to 8.04); Regression, Logistic NCT01294644 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Deoxycholic Acid | Unknown | 1 mg/m2 | Other |
| Subject | Deoxycholic Acid | Unknown | 2 mg/m2 | Other |
Indications
No indication recorded.