Deoxycholic Acid Injection for the Treatment of Superficial Lipomas

Phase 1

Completed

• Conditions: Lipoma
• Interventions: Drug: Deoxycholic Acid Injection; Drug: Placebo

• Registration Number: NCT00422188
• Lead Sponsor: Kythera Biopharmaceuticals

Brief Summary

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.

Detailed 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.)

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-01-11
• Study First Submitted QC: 2007-01-12
• Study First Posted: 2007-01-15
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-08
• Last Update Posted: 2015-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Deoxycholic Acid Injection 2.0%	Deoxycholic Acid Injection	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.
Placebo	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.
Deoxycholic Acid Injection 0.5%	Deoxycholic Acid Injection	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.
Deoxycholic Acid Injection 1.0%	Deoxycholic Acid Injection	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.
Deoxycholic Acid Injection 4.0%	Deoxycholic Acid Injection	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.

Primary Outcome Measures

Name	Time	Method
Assessments of Safety with Laboratory tests	up to 16 weeks
Assessments of Safety with ECG	up to 16 weeks
Assessments of Safety with Medical Evaluations	up to 16 weeks

Secondary Outcome Measures

Name	Time	Method
Lipoma size reduction	up to 16 weeks

Trial Locations

Locations (1)

Therapeutics Clinical Research; 🇺🇸 San Diego, California, United States