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

NCT02249052 | Completed Phase 2 Results

• 1 other identifier: 10-Lipoma II
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Lipoma

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 6 months post injection

Secondary Outcomes (3)

• Responder Analysis

  Baseline and 6 months

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

  Baseline and 6 months

• Subject Satisfaction

  6 months

Other Outcomes (2)

• Change in Visible Surface Area

  1 Month post injection

• Change in Visible Surface Area

  3 month post injection

Study Arms (2)

AA4500

ACTIVE COMPARATOR

single injection of 0.58 mg study drug

Drug: AA4500

Placebo

PLACEBO COMPARATOR

single injection of placebo

Drug: placebo

Interventions

AA4500 DRUG

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

Also known as: XIAFLEX, Collagenase Clostridium Histolyticum

AA4500

placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gerut, Zachary, M.D.: lead
• Advance Biofactures Corporation: collaborator

Study Sites (2)

Aesthetic Center

Hewlett, New York, 11557, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, 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, Sponsor/Investigator
• Organization: Dr. Zachary E. Gerut

zger@optonline.net

516 295-2100

Study Officials

• Zachary E Gerut, MD

  Private Practice

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2014
• First Posted: September 25, 2014
• Study Start: August 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: June 1, 2016
• Last Updated: February 23, 2017
• Results First Posted: December 13, 2016

Record last verified: 2016-08

Locations

US (2)