Clinical Trial: Deoxycholic Acid Injection for the Treatment of Superficial Lipomas
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase 1, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Dose-Escalation Study of the Pharmacokinetics, Safety, and Efficacy of ATX-101 (Sodium Deoxycholate for Injection) Intral
Brief Summary: The purpose of this research is to compare the safety and effectiveness of 4 different concentrations of deoxycholic acid injection against a placebo in the treatment of superficial lipomas.
Detailed Summary: A lipoma is a fatty lump typically located on the trunk, shoulder, arms or legs. For the purposes of this study, only lipomas on the trunk, arms, legs, or neck were treated. (Lipomas on the face, wrists, hands, lower portion of the spine, genitals, ankles, or feet were not treated.)
Sponsor: Kythera Biopharmaceuticals
Current Primary Outcome:
- Assessments of Safety with Laboratory tests [ Time Frame: up to 16 weeks ]
- Assessments of Safety with ECG [ Time Frame: up to 16 weeks ]
- Assessments of Safety with Medical Evaluations [ Time Frame: up to 16 weeks ]
Original Primary Outcome: Safety: Laboratory tests, ECG, Medical Evaluations
Current Secondary Outcome: Lipoma size reduction [ Time Frame: up to 16 weeks ]
Original Secondary Outcome: Lipoma size reduction
Information By: Kythera Biopharmaceuticals
Dates:
Date Received: January 11, 2007
Date Started: January 2007
Date Completion:
Last Updated: December 8, 2015
Last Verified: December 2015
