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

Primary Purpose

Lipoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AA4500
placebo
Sponsored by
Gerut, Zachary, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lipoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Aesthetic Center
  • Vanderbilt University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

AA4500

Placebo

Arm Description

single injection of 0.58 mg study drug

single injection of placebo

Outcomes

Primary Outcome Measures

Percent Change From Baseline in Surface Area of the Lipoma at Six Months
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 Outcome Measures

Responder Analysis
The number of participants with at least 50% decrease in visible lipoma surface area of lipoma relative to baseline
Percent Change From Baseline in Greatest Dimension (Length) of Lipoma at 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.
Subject Satisfaction
Subjects very satisfied or somewhat satisfied with study treatment based upon Subject Questionnaire

Full Information

First Posted
August 18, 2014
Last Updated
January 6, 2017
Sponsor
Gerut, Zachary, M.D.
Collaborators
Advance Biofactures Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02249052
Brief Title
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

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gerut, Zachary, M.D.
Collaborators
Advance Biofactures Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lipoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AA4500
Arm Type
Active Comparator
Arm Description
single injection of 0.58 mg study drug
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
single injection of placebo
Intervention Type
Drug
Intervention Name(s)
AA4500
Other Intervention Name(s)
XIAFLEX, Collagenase Clostridium Histolyticum
Intervention Description
Subjects must present with 2 lipomas; one to receive AA4500 and one to receive placebo simultaneously
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Surface Area of the Lipoma at Six Months
Description
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.
Time Frame
Baseline and 6 months post injection
Secondary Outcome Measure Information:
Title
Responder Analysis
Description
The number of participants with at least 50% decrease in visible lipoma surface area of lipoma relative to baseline
Time Frame
Baseline and 6 months
Title
Percent Change From Baseline in Greatest Dimension (Length) of Lipoma at 6 Months
Description
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.
Time Frame
Baseline and 6 months
Title
Subject Satisfaction
Description
Subjects very satisfied or somewhat satisfied with study treatment based upon Subject Questionnaire
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Change in Visible Surface Area
Description
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.
Time Frame
1 Month post injection
Title
Change in Visible Surface Area
Description
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.
Time Frame
3 month post injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zachary E Gerut, MD
Organizational Affiliation
Private Practice
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aesthetic Center
City
Hewlett
State/Province
New York
ZIP/Postal Code
11557
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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