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Case-control Study on Matrix Metalloproteinase Levels in Tissue in Patients With Keloid Scar

This study has been completed.
Sponsor:
Information provided by:
Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT01125137
First received: February 2, 2010
Last updated: January 10, 2011
Last verified: February 2010
History of Changes
  Purpose

Purpose:

To compare the levels of matrix metalloproteinase-1 (MMP-1), MMP-8, MMP-13 and tissue inhibitor of metalloproteinases (TIMPs) in keloid skin tissue with normal skin in the same patient and with normal discarded skin tissue (control). The investigators aim to correlate between levels of MMPs in patients with keloid scarring in comparison with normal and discarded tissue.


Condition Intervention
Keloid
 Procedure: Removal of Keloid

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Case-control Study on Matrix Metalloproteinase Levels in Tissue in Patients With Keloid Scar

Resource links provided by NLM:

MedlinePlus related topics: Scars
U.S. FDA Resources

Further study details as provided by Henry Ford Health System:

Primary Outcome Measures:
  • Correlate the level of matrix metalloproteinases in keloid tissue versus normal skin [ Time Frame: One time office visit for keloid excision, there will be no follow up visits for patient. Keloid tissue will be analyzed in Henry Ford Hospital laboratory after excision. ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: February 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Biopsy Procedure: Removal of Keloid
Keloid will be excised by Henry Ford Hospital Dermatologist, Dermatosurgeon or Plastic Surgeon.

Detailed Description:

The investigators anticipate enrolling 20 patients into our study. The COST of the excision and related procedures WILL NOT be covered by the research study. Patient and patient's health insurance provider will be responsible for all costs of treatment and related procedures.

  1. Patients must be at least 18 years old and have a keloid which they will agree to have biopsied.
  2. During a screening visit we will obtain determine if patient fulfills inclusion/exclusion criteria, obtain informed visit and HIPAA authorization. Demographic information and pertinent medical history will be obtained and risk factors will be explained to the patient.
  3. A focused dermatological exam will be performed assessing the severity and location of the keloid as well as skin phototype of the patient.
  4. A Henry Ford Hospital Dermatosurgeon will excise a biopsy of the keloid tissue and normal tissue from enrolled patients and the specimens will be sent to the lab for workup. Discarded skin samples will also be collected from Henry Ford Plastic Surgery and Dermatology department and analyzed as an additional control for normal skin. The discarded skin samples (controls) will be region specific and matched with a keloid sample that is from the same area of the body as the biopsy sample.
  5. Levels of MMP's will be measured in keloid, normal tissue samples and discarded skin samples.
  6. Levels of TIMPs will be measured in keloid, normal tissue and discarded tissue samples
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • For inclusion, the subject must:

    1. Be at least 18 years old;
    2. Have a keloid and accept to have it excised;
    3. Be able to understand the requirements for the study, the risks involved and are able to sign the informed consent form;
    4. Agree to follow and undergo all study-related procedures

Exclusion Criteria:

  • Subjects will be excluded if any of the following apply:

    1. Women who are lactating, pregnant, or planning to become pregnant;
    2. Patients with a recent history of serious systemic disease;
    3. Patients who are receiving treatment for the keloid or have received treatment in the past 1 year.
    4. Any reason the investigator feels the patient should not participate in the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01125137

Locations
United States, Michigan
Henry Ford Hospital Dermatology Dept. 3031 West Grand Blvd, Suite 800
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Henry Ford Health System
Investigators
Principal Investigator: Iltefat Hamzavi, M.D. Henry Ford Hospital
  More Information

No publications provided

Responsible Party: Dr. Iltefat Hamzavi, Henry Ford Hospital Department of Dermatology
ClinicalTrials.gov Identifier: NCT01125137     History of Changes
Other Study ID Numbers: IRB #5890
Study First Received: February 2, 2010
Last Updated: January 10, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Henry Ford Health System:
Keloid
MMP
Matrix metalloproteinase
dermatology

Additional relevant MeSH terms:
Keloid
Collagen Diseases
Connective Tissue Diseases
 Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013