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

Sponsored by:	Kythera Biopharmecuticals
Information provided by:	Kythera Biopharmecuticals
ClinicalTrials.gov Identifier:	NCT00422188

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 I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Kythera Biopharmecuticals:

Primary Outcome Measures:

Safety: Laboratory tests, ECG, Medical Evaluations

Secondary Outcome Measures:

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)

Detailed Description:

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00422188

Sponsors and Collaborators

Kythera Biopharmecuticals

Investigators

Principal Investigator:

Stacy R. Smith, M.D.

Therapeutics Clinical Research

More Information

Study ID Numbers:	ATX-101-06-04
Study First Received:	January 11, 2007
Last Updated:	February 1, 2008
ClinicalTrials.gov Identifier:	NCT00422188
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Neoplasms, Connective and Soft Tissue
Lipoma
Deoxycholic Acid

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Therapeutic Uses
Cholagogues and Choleretics

Gastrointestinal Agents
Pharmacologic Actions
Neoplasms, Adipose Tissue

ClinicalTrials.gov processed this record on January 16, 2009