Deoxycholic Acid Injection for the Treatment of Superficial Lipomas

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 Overview

• Status: Completed
• Conditions: Lipoma
• Intervention / Treatment: Drug: Deoxycholic Acid Injection; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Therapeutics Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Deoxycholic Acid Injection; Administered via intralipomal injection.; Other Names: ATX-101; Sodium deoxycholate
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.	Drug: Deoxycholic Acid Injection; Administered via intralipomal injection.; Other Names: ATX-101; Sodium deoxycholate
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.	Drug: Deoxycholic Acid Injection; Administered via intralipomal injection.; Other Names: ATX-101; Sodium deoxycholate
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.	Drug: Deoxycholic Acid Injection; Administered via intralipomal injection.; Other Names: ATX-101; Sodium deoxycholate
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.	Drug: Placebo; Administered via intralipomal injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Lipoma size reduction	up to 16 weeks

Collaborators and Investigators

• Sponsor: Kythera Biopharmaceuticals
• Investigators: Principal Investigator: Stacy R. Smith, M.D., Therapeutics Clinical Research

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): November 1, 2007
• Study Completion (Actual): November 1, 2007

Study Registration Dates

• First Submitted: January 11, 2007
• First Submitted That Met QC Criteria: January 12, 2007
• First Posted (Estimate): January 15, 2007

Study Record Updates

• Last Update Posted (Estimate): December 10, 2015
• Last Update Submitted That Met QC Criteria: December 8, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Adipose Tissue; Lipoma; Gastrointestinal Agents; Cholagogues and Choleretics; Deoxycholic Acid
• Other Study ID Numbers: ATX-101-06-04