Phase 2 Study for the Treatment of Superficial Lipomas

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kythera Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT00608842
First received: January 23, 2008
Last updated: May 30, 2014
Last verified: May 2014
  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
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Biopharmaceuticals:

Primary Outcome Measures:
  • Lipoma size reduction [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety assessments with Laboratory tests [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Safety assessments with ECG [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Safety assessments with 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: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ATX-101 (1mg/cm2) Drug: ATX-101
Other Name: sodium deoxycholate
Experimental: ATX-101 (4 mg/cm2) Drug: ATX-101
Other Name: sodium deoxycholate
Experimental: ATX-101 (8 mg/cm2) Drug: ATX-101
Other Name: sodium deoxycholate
Placebo Comparator: placebo Drug: 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Biopharmaceuticals
Investigators
Study Director: Patricia S. Walker, M.D., Ph.D. Kythera Biopharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Kythera Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT00608842     History of Changes
Other Study ID Numbers: ATX-101-07-05
Study First Received: January 23, 2008
Last Updated: May 30, 2014
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 July 26, 2014