Completed

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

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What is being tested

AA4500

+ placebo

Drug
Who is being recruted

Lipoma+2

+ Neoplasms

+ Neoplasms by Histologic Type

From 18 to 75 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: August 2014
See protocol details

Summary

Principal SponsorGerut, Zachary, M.D.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2014

Actual date on which the first participant was enrolled.

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.

Official TitleA Double Blind Study to Evaluate the Safety and Efficacy of Collagenase Clostridium Histolyticum (AA4500) in the Treatment of Lipoma
NCT02249052
Principal SponsorGerut, Zachary, M.D.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

19 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

LipomaNeoplasmsNeoplasms by Histologic TypeNeoplasms, Connective and Soft TissueNeoplasms, Adipose Tissue

Criteria

7 inclusion criteria required to participate
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
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9 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
single injection of 0.58 mg study drug

Group II

Placebo
single injection of placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

Aesthetic Center

Hewlett, United StatesOpen Aesthetic Center in Google Maps
Suspended

Vanderbilt University

Nashville, United States
Completed2 Study Centers