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Completed

NCT Number: NCT02249052

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

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

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Key information

Conditions

Lipoma Neoplasms Neoplasms by Histologic Type Neoplasms, Adipose Tissue Neoplasms, Connective and Soft Tissue

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Aesthetic Center, Hewlett, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AA4500

Drug

Subjects must present with 2 lipomas; one to receive AA4500 and one to receive placebo simultaneously

Other names: XIAFLEX, Collagenase Clostridium Histolyticum

Placebo

Drug

Placebo

Primary outcomes

  1. Percent Change From Baseline in Surface Area of the Lipoma at Six Months

    Time frame: Baseline and 6 months post injection

    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.

Secondary outcomes

  1. Responder Analysis

    Time frame: Baseline and 6 months

    The number of participants with at least 50% decrease in visible lipoma surface area of lipoma relative to baseline

  2. Percent Change From Baseline in Greatest Dimension (Length) of Lipoma at 6 Months

    Time frame: Baseline and 6 months

    Change from baseline in lipoma length Calculated as the percent change from baseline for length of the lipoma treated with AA4500 and the lipoma treated with placebo.

  3. Subject Satisfaction

    Time frame: 6 months

    Subjects very satisfied or somewhat satisfied with study treatment based upon Subject Questionnaire

Other outcomes

  1. Change in Visible Surface Area

    Time frame: 1 Month post injection

    Visible surface area is 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.

  2. Change in Visible Surface Area

    Time frame: 3 month post injection

    Visible surface area is 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.

Sponsors and collaborators

Lead sponsor

Gerut, Zachary, M.D.

Indiv

Collaborators

  • Advance Biofactures Corporation

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 25, 2014
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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