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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kythera Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT00422188
First received: January 11, 2007
Last updated: May 28, 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 (Sodium Deoxycholate for Injection)
Drug: Placebo
Phase 1

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

Primary Outcome Measures:
  • Assessments of Safety with Laboratory tests [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]
  • Assessments of Safety with ECG [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]
  • Assessments of Safety with Medical Evaluations [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lipoma size reduction [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: January 2007
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
placebo or ATX-101 (1 mg/cm2)
Drug: ATX-101 (Sodium Deoxycholate for Injection) Drug: Placebo
Experimental: Cohort 2
placebo or ATX-101 (2 mg/cm2)
Drug: ATX-101 (Sodium Deoxycholate for Injection) Drug: Placebo
Experimental: Cohort 3
Placebo or ATX-101 (4 mg/cm2)
Drug: ATX-101 (Sodium Deoxycholate for Injection) Drug: Placebo
Experimental: Cohort 4
Placebo or ATX-101 (8 mg/cm2)
Drug: ATX-101 (Sodium Deoxycholate for Injection) Drug: Placebo
Experimental: Optional Cohort 5
Depending upon the tolerability profile exhibited in the 8 mg/cm2 group, an additional double blind cohort of 4 subjects could be enrolled to evaluate additional concentrations of ATX-101 or placebo.
Drug: ATX-101 (Sodium Deoxycholate for Injection) 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.
  • 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
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: NCT00422188

Locations
United States, California
Therapeutics Clinical Research
San Diego, California, United States, 92123
Sponsors and Collaborators
Kythera Biopharmaceuticals
Investigators
Principal Investigator: Stacy R. Smith, M.D. Therapeutics Clinical Research
  More Information

No publications provided

Responsible Party: Kythera Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT00422188     History of Changes
Other Study ID Numbers: ATX-101-06-04
Study First Received: January 11, 2007
Last Updated: May 28, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lipoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Adipose Tissue
Neoplasms, Connective and Soft Tissue
Deoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014