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

Lipoma Clinical Trial

Official title:

A Double Blind Study to Evaluate the Safety and Efficacy of Collagenase Clostridium Histolyticum (AA4500) in the Treatment of Lipoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02249052
• Other study ID #: 10-Lipoma II
• Status: Completed
• Phase: Phase 2
• First received: August 18, 2014
• Last updated: August 25, 2016
• Start date: August 2014
• Est. completion date: June 2016

Study information

• Verified date: August 2016
• Source: Gerut, Zachary, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lipoma

Intervention

Drug:
• AA4500
Subjects must present with 2 lipomas; one to receive AA4500 and one to receive placebo simultaneously
• placebo
Placebo

Locations

Country	Name	City	State
United States	Aesthetic Center	Hewlett	New York
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Gerut, Zachary, M.D.	Advance Biofactures Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subject Questionnaire to assess satisfaction with treatment	Subject assessment of satisfaction to assess with treatment for both drug and placebo injected lipomas using a questionnaire	6 months	No
Primary	Reduction in visible surface area of the lipoma	The primary efficacy outcome is lipoma visible surface area defined as the longest dimension ("length") times the longest dimension perpendicular to length ("width"). Visible surface area will be analyzed as the percent change from baseline at the 6-month visit.	6 months post injection	No
Secondary	Number participants with 50% or greater reduction in lipoma surface area relative to baseline	The percent of subjects with at least 50% reduction in visible lipoma surface area will be compared for drug treated and placebo treated lipomas	6 months	No
Secondary	Superiority of study drug over placebo	Assessment of reduction in lipoma surface area of drug versus placebo	6 months	No