Case-control Study on Matrix Metalloproteinase Levels in Tissue in Patients With Keloid Scar
Primary Purpose
Keloid
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Removal of Keloid
Sponsored by
About this trial
This is an interventional basic science trial for Keloid focused on measuring Keloid, MMP, Matrix metalloproteinase, dermatology
Eligibility Criteria
Inclusion Criteria:
For inclusion, the subject must:
- Be at least 18 years old;
- Have a keloid and accept to have it excised;
- Be able to understand the requirements for the study, the risks involved and are able to sign the informed consent form;
- Agree to follow and undergo all study-related procedures
Exclusion Criteria:
Subjects will be excluded if any of the following apply:
- Women who are lactating, pregnant, or planning to become pregnant;
- Patients with a recent history of serious systemic disease;
- Patients who are receiving treatment for the keloid or have received treatment in the past 1 year.
- Any reason the investigator feels the patient should not participate in the study.
Sites / Locations
- Henry Ford Hospital Dermatology Dept. 3031 West Grand Blvd, Suite 800
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Biopsy
Arm Description
Outcomes
Primary Outcome Measures
Correlate the level of matrix metalloproteinases in keloid tissue versus normal skin
Secondary Outcome Measures
Full Information
NCT ID
NCT01125137
First Posted
February 2, 2010
Last Updated
January 10, 2011
Sponsor
Henry Ford Health System
1. Study Identification
Unique Protocol Identification Number
NCT01125137
Brief Title
Case-control Study on Matrix Metalloproteinase Levels in Tissue in Patients With Keloid Scar
Official Title
Case-control Study on Matrix Metalloproteinase Levels in Tissue in Patients With Keloid Scar
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Henry Ford Health System
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
Patients must be at least 18 years old and have a keloid which they will agree to have biopsied.
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.
A focused dermatological exam will be performed assessing the severity and location of the keloid as well as skin phototype of the patient.
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.
Levels of MMP's will be measured in keloid, normal tissue samples and discarded skin samples.
Levels of TIMPs will be measured in keloid, normal tissue and discarded tissue samples
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keloid
Keywords
Keloid, MMP, Matrix metalloproteinase, dermatology
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Biopsy
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Removal of Keloid
Intervention Description
Keloid will be excised by Henry Ford Hospital Dermatologist, Dermatosurgeon or Plastic Surgeon.
Primary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
For inclusion, the subject must:
Be at least 18 years old;
Have a keloid and accept to have it excised;
Be able to understand the requirements for the study, the risks involved and are able to sign the informed consent form;
Agree to follow and undergo all study-related procedures
Exclusion Criteria:
Subjects will be excluded if any of the following apply:
Women who are lactating, pregnant, or planning to become pregnant;
Patients with a recent history of serious systemic disease;
Patients who are receiving treatment for the keloid or have received treatment in the past 1 year.
Any reason the investigator feels the patient should not participate in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iltefat Hamzavi, M.D.
Organizational Affiliation
Henry Ford Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henry Ford Hospital Dermatology Dept. 3031 West Grand Blvd, Suite 800
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Case-control Study on Matrix Metalloproteinase Levels in Tissue in Patients With Keloid Scar
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