Double Blind Study to Evaluate the Efficacy of Collagenase Histolyticum in the Treatment of Lipoma

Gerut, Zachary, M.D.

Status and phase

Completed

Phase 2

Conditions

Lipoma

Treatments

Drug: AA4500

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02249052

10-Lipoma II

Details and patient eligibility

About

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

Full 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.

Enrollment

19 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

18-75 years of age, of either sex or any race
Clinical history of at least 2 lipomas for at least one year
Lipomas diagnosed as benign
Two lipomas on distinctly separate parts of the body, or on the torso if 30 cm apart, with easily definable edges
Each lipoma is a single mass with easily definable edges
Lipomas are 5 to 24 cm squared
Women of childbearing potential must use an acceptable method of birth control

Exclusion criteria

Lipomas on the head, neck, hand or foot, or female breast
Women who are nursing or pregnant
Multi-lobular lipomas
Subjects who have received an investigational drug within 30 days before receiving the first dose of study drug in this study
Subjects with a known allergy to collagenase or any of the inactive ingredients in XIAFLEX
Subjects with uncontrolled diabetes, hypertension, or thyroid disease, or any medical condition that would make the subject unsuitable for enrollment
Subjects having prior treatment or trauma of the lipoma that could interfere with study assessments
Subjects with a history of connective tissue diseases, rheumatological diseases
Subjects taking anticoagulants or planning to receive anticoagulants (except for lo dose aspirin and over-the-counter nonsteroidal anti-inflammatory drugs) within 7 days of injection of study drug