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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01125137
Recruitment Status : Completed
First Posted : May 18, 2010
Last Update Posted : January 11, 2011
Information provided by:
Henry Ford Health System

Brief Summary:


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 or disease Intervention/treatment Phase
Keloid Procedure: Removal of Keloid Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Case-control Study on Matrix Metalloproteinase Levels in Tissue in Patients With Keloid Scar
Study Start Date : February 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Biopsy Procedure: Removal of Keloid
Keloid will be excised by Henry Ford Hospital Dermatologist, Dermatosurgeon or Plastic Surgeon.

Primary Outcome Measures :
  1. 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. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01125137

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
Principal Investigator: Iltefat Hamzavi, M.D. Henry Ford Hospital

Responsible Party: Dr. Iltefat Hamzavi, Henry Ford Hospital Department of Dermatology Identifier: NCT01125137     History of Changes
Other Study ID Numbers: IRB #5890
First Posted: May 18, 2010    Key Record Dates
Last Update Posted: January 11, 2011
Last Verified: February 2010

Keywords provided by Henry Ford Health System:
Matrix metalloproteinase

Additional relevant MeSH terms:
Collagen Diseases
Connective Tissue Diseases
Pathologic Processes