drugset / Trial / NCT01032889

Deoxycholic Acid Injection Submental Fat (SMF) Magnetic Resonance Imaging (MRI) and Subject-reported Outcome Measures Study

NCT01032889 ↗

Phase 2 Completed 129 enrolled Kythera Biopharmaceuticals
RandomizedParallel-groupDouble-blindTreatment

Summary

Evaluation of the safety, tolerability and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin).

Timeline

Start
2009-12
Primary completion
2010-12
Completion
2010-12

Outcome

Mixed primary results

registry Deoxycholic Acid Injection 1 mg/cm² vs Placebo; p = 0.052; Difference from placebo -0.3 (95% CI -0.61 to 0.00) NCT01032889 ↗

registry Deoxycholic Acid Injection 2 mg/cm² vs Placebo; p = 0.003; Difference from placebo -0.5 (95% CI -0.77 to -0.16) NCT01032889 ↗

registry Deoxycholic Acid Injection 1 mg/cm² vs Placebo; p = 0.117; Difference from placebo -0.2 (95% CI -0.55 to 0.06) NCT01032889 ↗

registry Deoxycholic Acid Injection 2 mg/cm² vs Placebo; p <0.001; Difference from placebo -0.6 (95% CI -0.91 to -0.30) NCT01032889 ↗

registry Deoxycholic Acid Injection 1 mg/cm² vs Placebo; p = 0.005; Difference from placebo -1.4 (95% CI -2.44 to -0.46) NCT01032889 ↗

registry Deoxycholic Acid Injection 2 mg/cm² vs Placebo; p <0.001; Difference from placebo -2.5 (95% CI -3.48 to -1.48) NCT01032889 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Deoxycholic acid injection Unknown 1 unknown —
Subject Deoxycholic acid injection Unknown 2 unknown —

Indications

No indication recorded.