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

Information source: Gerut, Zachary, M.D.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lipoma

Intervention: AA4500 (Drug); placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Gerut, Zachary, M.D.

Official(s) and/or principal investigator(s):
Zachary E Gerut, MD, Principal Investigator, Affiliation: Private Practice

Overall contact:
Zachary E Gerut, M.D., Phone: 516-295-2100, Email: officemanager@drgerut.com

Summary

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

Clinical Details

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

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

Primary outcome: Reduction in visible surface area of the lipoma

Secondary outcome:

Number participants with 50% or greater reduction in lipoma surface area relative to baseline

Superiority of study drug over placebo

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

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

Locations and Contacts

Zachary E Gerut, M.D., Phone: 516-295-2100, Email: officemanager@drgerut.com

Aesthetic Center, Hewlett, New York 11557, United States; Recruiting
Zachary E Gerut, M.D., Phone: 516-295-2100, Email: officemanager@drgerut.com
Zachary E Gerut, M.D., Principal Investigator

Vanderbilt University, Nashville, Tennessee 37232, United States; Recruiting
Bruce R Shack, M.D., Principal Investigator

Additional Information

Starting date: August 2014
Last updated: November 12, 2014

Page last updated: August 23, 2015

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