ATX-101 (Sodium Deoxycholate for Injection) Phase 2 Study for the Treatment of Superficial Lipomas - Full Text View

Sponsored by:	Kythera Biopharmecuticals
Information provided by:	Kythera Biopharmecuticals
ClinicalTrials.gov Identifier:	NCT00608842

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	Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by Kythera Biopharmecuticals:

Primary Outcome Measures:

Lipoma size reduction [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety: Laboratory tests, ECG, Medical Evaluations [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]

Enrollment:	62
Study Start Date:	November 2007
Study Completion Date:	October 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental ATX-101	Drug: ATX-101 ATX-101 or placebo
2: Placebo Comparator Placebo	Drug: ATX-101 ATX-101 or placebo

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.
Signed informed consent.

Exclusion Criteria:

Absence of significant medical conditions that could affect safety.
History of 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: NCT00608842

Locations

United States, Alabama
Gary D. Monheit, M.D.
Birmingham, Alabama, United States, 35205
United States, California
Stacy R. Smith
San Diego, California, United States, 92123
United States, Michigan
Steven Grekin, D.O.
Warren, Michigan, United States, 48088
United States, Nebraska
Joel Schlessinger, M.D.
Omaha, Nebraska, United States, 68144
United States, New Jersey
David J. Goldberg, M.D.
Westwood, New Jersey, United States, 07675
United States, New York
Neil S. Sadick, M.D.
New York, New York, United States, 10021
United States, Tennessee
Michael H. Gold, M.D.
Nashville, Tennessee, United States, 37215

Sponsors and Collaborators

Kythera Biopharmecuticals

Investigators

Study Director:

Patricia S. Walker, M.D., Ph.D.

Kythera Biopharmaceuticals, Inc.

More Information

No publications provided

Responsible Party:	Kythera Biopharmaceuticals, Inc. ( Daniel R. Lee )
Study ID Numbers:	ATX-101-07-05, ATX-101-07-05
Study First Received:	January 23, 2008
Last Updated:	February 9, 2009
ClinicalTrials.gov Identifier:	NCT00608842 History of Changes
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, Connective and Soft Tissue
Neoplasms
Neoplasms by Histologic Type
Therapeutic Uses
Cholagogues and Choleretics

Lipoma
Gastrointestinal Agents
Deoxycholic Acid
Pharmacologic Actions
Neoplasms, Adipose Tissue

ClinicalTrials.gov processed this record on May 07, 2009