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

Keloid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01125137
• Other study ID #: IRB #5890
• Status: Completed
• Phase: N/A
• Start date: February 2010
• Est. completion date: January 2011

Study information

• Verified date: April 2024
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Keloid

Intervention

Procedure:
• Removal of Keloid
Keloid will be excised by Henry Ford Hospital Dermatologist, Dermatosurgeon or Plastic Surgeon.

Locations

Country	Name	City	State
United States	Henry Ford Hospital Dermatology Dept. 3031 West Grand Blvd, Suite 800	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlate the level of matrix metalloproteinases in keloid tissue versus normal skin		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.