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

Brief Summary

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”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
  • Study Primary Completion Date: November 2007

Detailed Clinical Trial 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.)

Interventions Used in this Clinical Trial

  • Drug: ATX-101 (Sodium Deoxycholate for Injection)
  • Drug: Placebo

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Cohort 1
    • placebo or ATX-101 (1 mg/cm2)
  • Experimental: Cohort 2
    • placebo or ATX-101 (2 mg/cm2)
  • Experimental: Cohort 3
    • Placebo or ATX-101 (4 mg/cm2)
  • Experimental: Cohort 4
    • Placebo or ATX-101 (8 mg/cm2)
  • 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.

Outcome Measures for this Clinical Trial

Primary Measures

  • Assessments of Safety with Laboratory tests
    • Time Frame: up to 16 weeks
      Safety Issue?: No
  • Assessments of Safety with ECG
    • Time Frame: up to 16 weeks
      Safety Issue?: No
  • Assessments of Safety with Medical Evaluations
    • Time Frame: up to 16 weeks
      Safety Issue?: No

Secondary Measures

  • Lipoma size reduction
    • Time Frame: up to 16 weeks
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Kythera Biopharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Stacy R. Smith, M.D., Principal Investigator, Therapeutics Clinical Research

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00422188