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

NCT01613313 | Completed Phase 2 Results

• 1 other identifier: Lipoma DE/01
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lipoma

Keywords

Lipoma; Fatty Tumor

Outcome Measures

Primary Outcomes (1)

• Change in Visible Surface Area of the Lipoma

  The primary efficacy outcome is the visible surface area of the lipoma measured as the longest dimension (length) times the longest dimension perpendicular to length (width). Visible surface area will be determined by caliper and will be analyzed as the percent change from baseline at the 6-month post injection visit.

  Baseline and Six months post injection of study drug

Secondary Outcomes (1)

• Relative Change in Volume of the Lipoma

  Baseline and 6 months post injection of study drug

Study Arms (4)

Dose #1

EXPERIMENTAL

single injection 0.058 mg Collagenase Clostridium Histolyticum

Drug: Collagenase Clostridium Histolyticum

Dose #2

EXPERIMENTAL

single injection 0.15 mg Collagenase Clostridium Histolyticum

Drug: Collagenase Clostridium Histolyticum

Dose #3

EXPERIMENTAL

single injection 0.29 mg Collagenase Clostridium Histolyticum

Drug: Collagenase Clostridium Histolyticum

Dose #4

EXPERIMENTAL

single injection 0.44 mg Collagenase Clostridium Histolyticum

Drug: Collagenase Clostridium Histolyticum

Interventions

Collagenase Clostridium Histolyticum DRUG

This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg.

Also known as: XIAFLEX

Dose #1; Dose #2; Dose #3; Dose #4

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zachary Gerut: lead
• Advance Biofactures Corporation: collaborator

Study Sites (1)

Zachary E. Gerut, M.D.

Hewlett, New York, 11557, United States

Location

MeSH Terms

Conditions

Lipoma

Interventions

Microbial Collagenase

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Collagenases; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases

Results Point of Contact

• Title: Dr. Zachary E.Gerut
• Organization: GerutZ

Drgerut@drgerut.com

516 295-2100

Study Officials

• Zachary E Gerut, M.D.

  Gerut, Zachary, M.D.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: June 5, 2012
• First Posted: June 7, 2012
• Study Start: May 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: October 1, 2013
• Last Updated: October 6, 2016
• Results First Posted: March 9, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)