CompletedPhase 2

A Dose Escalation Study Using Collagenase Clostridium Histolyticum in the Treatment of Lipoma

United States14 participantsStarted 2012-05

Plain-language summary

The purpose of this research is to evaluate the safest and most effective dose of a Food and Drug Administration (FDA) approved drug (XIAFLEX) in the treatment of lipoma (fatty tumors of varying sizes that occur commonly in the adult population). 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Clinical history lipoma at least one year and no treatment within last 90 days * Lipoma diagnosed as benign * Lipoma is a single mass with easily definable edges * Lipoma has an area of 2.0 to 17 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 * Subjects who have participated in any investigational drug trial within 45 days of enrollment in this study * Subjects with known allergy to collagenase or any of the inactive ingredients in XIAFLEX * Subjects with diabetes or any medical condition that would make the subject unsuitable for enrollment. * Subjects having a history of trauma in the area of the lipoma * Subjects with a history of connective tissue diseases or rheumatological diseases. * Subjects with uncontrolled hypertension * Subjects currently receiving or planning to receive anticoagulant medication except for less than 150 mg aspirin daily and over-the-counter nonsteroidal anti-inflammatory drugs) within 7 days before injection of study drug * Subjects having the following laboratory abnormalities: * ALT/AST greater than 3 times the upper limit of normal * Creatinine greater than 2 * Hemoglobin/hematocrit and WBC outside the normal range

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Visible Surface Area of the Lipoma

Timeframe: Baseline and Six months post injection of study drug

Trial details

NCT IDNCT01613313

SponsorZachary Gerut

Sponsor typeINDIV

Study typeINTERVENTIONAL

Primary completion2013-09

Results submitted2016-02-10

View on ClinicalTrials.gov More Lipoma trials