Deoxycholic Acid Injection for the Treatment of Superficial Lipomas

Brief Summary

Official Title: “Phase 1, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential 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 4 different concentrations of deoxycholic acid injection against a placebo 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

A lipoma is a fatty lump typically located on the trunk, shoulder, arms or legs. For the purposes of this study, only lipomas on the trunk, arms, legs, or neck were treated. (Lipomas on the face, wrists, hands, lower portion of the spine, genitals, ankles, or feet were not treated.)

Interventions Used in this Clinical Trial

  • Drug: Deoxycholic Acid Injection
    • Administered via intralipomal injection.
  • Drug: Placebo
    • Administered via intralipomal injection.

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Deoxycholic Acid Injection 0.5%
    • Participants received 0.5% deoxycholic acid administered at a volume dependent on the size of the lipoma up to a maximum of 5 mL for 2 treatments at 28-day intervals.
  • Experimental: Deoxycholic Acid Injection 1.0%
    • Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma up to a maximum of 5 mL for 2 treatments at 28-day intervals.
  • Experimental: Deoxycholic Acid Injection 2.0%
    • Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma up to a maximum of 5 mL for 2 treatments at 28-day intervals.
  • Experimental: Deoxycholic Acid Injection 4.0%
    • Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma up to a maximum of 5 mL for 2 treatments at 28-day intervals.
  • Placebo Comparator: Placebo
    • Participants received matching vehicle placebo administered at a volume dependent on the size of the lipoma up to a maximum of 5 mL for 2 treatments at 28-day intervals.

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 2 perpendicular diameters, and have the following characteristics:
  • History of slow growth followed by dormancy, and stable for at least 6 months.
  • Greatest length by greatest perpendicular width between 1 and 16 square centimeters, inclusive
  • Discrete, oval to 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 kg/m²
  • 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