NCT00422188

Deoxycholic Acid Injection for the Treatment of Superficial Lipomas

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) Intralipomal Injections for the Treatment of Superficial Lipomas

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Kythera Biopharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 description

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.)

Conditions

• Lipoma

Interventions

Type	Name	Description
DRUG	Deoxycholic Acid Injection	Administered via intralipomal injection.
DRUG	Placebo	Administered via intralipomal injection.

Timeline

• Start date: 2007-01-01
• Primary completion: 2007-11-01
• Completion: 2007-11-01
• First posted: 2007-01-15
• Last updated: 2015-12-10

Locations

1 site across 1 country: United States