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Sponsored by: |
Kythera Biopharmecuticals |
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Information provided by: | Kythera Biopharmecuticals |
ClinicalTrials.gov Identifier: | NCT00608842 |
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 |
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 |
Enrollment: | 62 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | August 2008 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
ATX-101 1.0%
|
Drug: ATX-101
ATX-101 1.0%, 2.0%, 4.0%, or placebo
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2: Experimental
ATX-101 2.0%
|
Drug: ATX-101
ATX-101 1.0%, 2.0%, 4.0%, or placebo
|
3: Experimental
ATX-101 4.0%
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Drug: ATX-101
ATX-101 1.0%, 2.0%, 4.0%, or placebo
|
4: Placebo Comparator
Placebo
|
Drug: ATX-101
ATX-101 1.0%, 2.0%, 4.0%, or placebo
|
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.)
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:
Exclusion Criteria:
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 |
Study Director: | Patricia S. Walker, M.D., Ph.D. | Kythera Biopharmaceuticals, Inc. |
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 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00608842 |
Health Authority: | United States: Food and Drug Administration |
Neoplasms, Connective and Soft Tissue Lipoma Deoxycholic Acid |
Neoplasms Neoplasms by Histologic Type Therapeutic Uses Cholagogues and Choleretics |
Gastrointestinal Agents Pharmacologic Actions Neoplasms, Adipose Tissue |