Deoxycholic Acid Injection for the Treatment of Superficial Lipomas

Kythera Biopharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Lipoma

Treatments: Drug: Placebo; Drug: Deoxycholic Acid Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT00422188

ATX-101-06-04

Details and patient eligibility

About

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.

Full 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.)

Enrollment: 16 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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16 participants in 5 patient groups, including a placebo group

Deoxycholic Acid Injection 0.5%

Experimental group

Description:

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.

Treatment:

Drug: Deoxycholic Acid Injection

Deoxycholic Acid Injection 1.0%

Experimental group

Description:

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.

Treatment:

Drug: Deoxycholic Acid Injection

Deoxycholic Acid Injection 2.0%

Experimental group

Description:

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.

Treatment:

Drug: Deoxycholic Acid Injection

Deoxycholic Acid Injection 4.0%

Experimental group

Description:

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.

Treatment:

Drug: Deoxycholic Acid Injection

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo