Trials / Completed
CompletedNCT00608842
Phase 2 Study for the Treatment of Superficial Lipomas
Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of ATX-101 (Sodium Deoxycholate for Injection) Intralipomal Injections for the Treatment of Superficial Lipomas
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 62 (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 3 different concentrations of deoxycholic acid for 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Deoxycholic Acid Injection | Administered via intralipomal injection. |
| DRUG | Placebo | Matching vehicle placebo administered via intralipomal injection. |
Timeline
- Start date
- 2007-11-01
- Primary completion
- 2008-08-01
- Completion
- 2010-01-01
- First posted
- 2008-02-06
- Last updated
- 2016-01-14
- Results posted
- 2016-01-14
Locations
7 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00608842. Inclusion in this directory is not an endorsement.