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ATX-101 (Sodium Deoxycholate for Injection) for the Treatment of Superficial Lipomas

This study has been completed.
Sponsor:
Information provided by:
Kythera Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT00422188
First received: January 11, 2007
Last updated: February 1, 2008
Last verified: February 2008
History of Changes

January 11, 2007
February 1, 2008
December 2006
October 2007   (final data collection date for primary outcome measure)
Safety: Laboratory tests, ECG, Medical Evaluations
Same as current
Complete list of historical versions of study NCT00422188 on ClinicalTrials.gov Archive Site
Lipoma size reduction
Same as current
 
 
 
ATX-101 (Sodium Deoxycholate for Injection) for the Treatment of Superficial Lipomas
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

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.

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.)
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Lipoma
Drug: ATX-101 (Sodium Deoxycholate for Injection)
 
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
October 2007
October 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00422188
ATX-101-06-04
 
 
Kythera Biopharmaceuticals
 
Principal Investigator: Stacy R. Smith, M.D. Therapeutics Clinical Research
Kythera Biopharmaceuticals
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP