ATX-101 (Sodium Deoxycholate for Injection) for the Treatment of Superficial Lipomas
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Purpose
The purpose of this research is to compare the safety and effectiveness of three different concentrations (amount of study drug in a liquid preparation) of an investigational drug (sodium deoxycholate for injection) solution against a placebo (a solution that looks similar but does not have any active drug in it) in the treatment of superficial lipomas.
| Condition | Intervention | Phase |
|---|---|---|
|
Lipoma |
Drug: ATX-101 (Sodium Deoxycholate for Injection) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study of the Pharmacokinetics, Safety, and Efficacy of ATX-101 (Sodium Deoxycholate for Injection) Intralipomal Injections for the Treatment of Superficial Lipomas |
- Safety: Laboratory tests, ECG, Medical Evaluations
- Lipoma size reduction
| Enrollment: | 16 |
| Study Start Date: | December 2006 |
| Study Completion Date: | October 2007 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
The purpose of this research is to compare the safety and effectiveness of three different concentrations (amount of study drug in a liquid preparation) of an investigational drug (sodium deoxycholate for injection) solution against a placebo (a solution that looks similar but does not have any active drug in it) in the treatment of superficial lipomas. Sodium deoxycholate for injection is a chemical similar to the one produced by the body. A lipoma is a fatty lump typically located on the trunk, shoulder, arms and legs. For the purposes of this study, only lipomas on the trunk, arms, legs or neck will be treated. (Lipomas on the face, wrists, hands, lower portion of the spine, genitals, ankles or feet will not be treated.)
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
One or more lipomas, based on clinical diagnosis, which are accessible for treatment and assessment, are quantifiable along at least two perpendicular diameters, and have the following characteristics:
- History of slow growth followed by dormancy, and stable for at least six months.
- Greatest length by greatest perpendicular width between 1 and 16 square centimeters
- Discrete, oval tor rounded in shape, not hard or attached to underlying tissue.
- Located on the trunk, arms, legs, or neck.
- Stable body weight with a body mass index of less than 30.
- Signed informed consent.
Exclusion Criteria:
- Absence of significant medical conditions that could affect safety.
- History of surgical treatment for lipomas.
- Treatment with an investigational agent within 30 days before ATX-101 treatment.
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00422188 History of Changes |
| Other Study ID Numbers: | ATX-101-06-04 |
| Study First Received: | January 11, 2007 |
| Last Updated: | February 1, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Lipoma Neoplasms, Adipose Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms |
Deoxycholic Acid Cholagogues and Choleretics Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013