Conditions: Lipoma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 19
Healthy volunteers: yes

Brief summary:
The purpose of this study is to determine whether collagenase is effective in reducing the surface area of a subcutaneous benign lipoma.

Detailed description:
This study will evaluate the safety and efficacy of a Food and Drug Administration (FDA) approved drug (XIAFLEX) in the treatment of lipoma (fatty tumors). The fat in the lipoma is like normal fat except that it is enclosed in a balloon-like structure which is made of collagen (fibrous tissue). Treatment of the lipoma with an injection of XIAFLEX (a protein that breaks down collagen fibers) may dissolve the collagen/fibrous strands thereby decreasing the size of the lipoma or removing it. Each subject must have two lipomas; one lipoma to be treated with placebo and one lipoma to be treated with study drug, both to be observed similarly throughout the trial.

Arms:
arm 1: single injection of 0.58 mg study drug arm 2: single injection of placebo

Interventions: intervention 1: AA4500 intervention 2: placebo
Intervention descriptions: intervention 1: Subjects must present with 2 lipomas; one to receive AA4500 and one to receive placebo simultaneously intervention 2: Placebo

Protocol document: