Phase 2 Study for the Treatment of Superficial Lipomas

Kythera Biopharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Lipoma

Treatments: Drug: Deoxycholic Acid Injection; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00608842

ATX-101-07-05

Details and patient eligibility

About

The purpose of this research is to compare the safety and effectiveness of 3 different concentrations of deoxycholic acid for 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: 62 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• One or more lipomas, based on clinical and histological 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 multiplied by greatest perpendicular width between 1 and 16 cm², inclusive
  • Discrete, oval to rounded in shape, not hard or attached to underlying tissue
  • Without changes in overlying skin (ie, inflammation, pain or tenderness, hyperpigmentation)
  • Located on the trunk, arms, legs, or neck

• Signed informed consent.

Exclusion criteria

• Absence of significant medical conditions that could affect safety
• History of surgical or deoxycholate 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: Quadruple Blind

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62 participants in 4 patient groups, including a placebo group

Deoxycholic Acid 1%

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 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.

Treatment:

Drug: Deoxycholic Acid Injection

Deoxycholic Acid 2%

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 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.

Treatment:

Drug: Deoxycholic Acid Injection

Deoxycholic Acid 4%

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 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.

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 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.

Treatment:

Drug: Placebo