Clinical trial NCT02249052: Double Blind Study to Evaluate the Efficacy of Collagenase Histolyticum in the Treatment of Lipoma
Official title: A Double Blind Study to Evaluate the Safety and Efficacy of Collagenase Clostridium Histolyticum (AA4500) in the Treatment of Lipoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lipoma
Lead sponsor: Gerut, Zachary, M.D.
Sponsor class: INDIV
Collaborators: name: Advance Biofactures Corporation
First posted: 2014-09-25
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent Change From Baseline in Surface Area of the Lipoma at Six Months
timeFrame: Baseline and 6 months post injection
Secondary outcomes:
measure: Responder Analysis
timeFrame: Baseline and 6 months
measure: Percent Change From Baseline in Greatest Dimension (Length) of Lipoma at 6 Months
timeFrame: Baseline and 6 months
measure: Subject Satisfaction
timeFrame: 6 months
Other outcomes:
measure: Change in Visible Surface Area
timeFrame: 1 Month post injection
measure: Change in Visible Surface Area
timeFrame: 3 month post injection
Locations:
city: Hewlett
country: United States
facility: Aesthetic Center
state: New York
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Private Practice
name: Zachary E Gerut, MD
role: PRINCIPAL_INVESTIGATOR
References: