Evaluation of the Initial Safety and Efficacy of Keloid Lesions Treated With MF-4181

March 12, 2012 updated by: Halscion, Inc.

A Prospective, Randomized, Comparative Feasibility Study Evaluating the Initial Safety and Efficacy of Keloid Lesions Treated With MF-4181 Adjunctive to Surgical Scar Revision

The objective of the study is to evaluate the initial safety and efficacy of MF-4181, a hydrogel scaffold, in the reduction of the volume, appearance, and/or symptoms associated with keloid scarring in subjects undergoing surgical revision of keloid scars.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Nassau, Bahamas
        • Princess Margaret Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 50 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female subjects 15 to 50 years of age each having at least one keloid scar on the ear. (If both ears have keloids, both ears may be treated with E-Matrix).
  • Keloids that have not undergone more than two surgical revisions (laser, cryotherapy or surgery)
  • Keloids that have been present for ≥ 1 year.
  • The keloid must measure ≥ 0.5 cm and not extend onto other portions of the head, neck, or face.
  • Able and willing to give written informed consent. (Age 15-17 must have written informed consent of legal guardian).
  • Willing to comply with the follow up schedule for a minimum of 6 months.

Exclusion Criteria:

  • Subjects with history of prior treatment at the study site or prior treatment of the keloid in the previous 6 weeks.
  • Pregnant or planning to become pregnant during the course of the study.
  • Heart disease or history of congestive heart failure.
  • Advanced or poorly controlled diabetes.
  • Current or history of heavy smoking (i.e., 10 pack years)
  • Active local infection at the treatment site and/or systemic infection.
  • History of or active central nervous system disease.
  • History of fever, migraine headaches, and/or recurrent upper respiratory infection.
  • Active collagen vascular disease or vasculitis, e.g., systemic lupus erythematosus, polyarthritis, dermatomyositis, systemic scleroderma or thrombotic thrombocytopenic purpura.
  • Unwilling or unable to return for follow-up visits.
  • Unwilling to refrain from use of any other scar treatment therapy/scar improving product, during the study, including steroid injections.
  • Regular, continuous use of systemic corticosteroid therapy or topical corticosteroid use in the area to be treated.
  • Current participation or participation within the last 3 months in the study of an investigational drug, device, or biologic.
  • Unable or unwilling to follow post-operative instructions.
  • Known hypersensitivity to MF-4181, collagen, dextran, or any of its constituent materials.
  • Known hypersensitivities to animal-based products
  • Previous participation in this study to avoid multiple enrollments of an individual subject.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device safety
Time Frame: 6 months
Device safety is defined as the incidence of device related adverse events.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device efficacy
Time Frame: 12 months
Evaluations of cosmesis, induration, erythema and pigmentation will be evaluated by the investigator.
12 months
Device efficacy
Time Frame: 12 months
Volume and linear measurements will be taken by the investigator
12 months
Device efficacy
Time Frame: 12 months
Subject evaluation of cosmesis, pain, tenderness, itching and scar satisfaction will be obtained.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Srikanth Garikaparthi, MD, Princess Margaret Hospital, Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

October 2, 2011

First Submitted That Met QC Criteria

October 4, 2011

First Posted (ESTIMATE)

October 5, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

March 13, 2012

Last Update Submitted That Met QC Criteria

March 12, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • HAL-0127

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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