Case-control Study on Matrix Metalloproteinase Levels in Tissue in Patients With Keloid Scar
|ClinicalTrials.gov Identifier: NCT01125137|
Recruitment Status : Completed
First Posted : May 18, 2010
Last Update Posted : January 11, 2011
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|
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
|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|
Procedure: Removal of Keloid
Keloid will be excised by Henry Ford Hospital Dermatologist, Dermatosurgeon or Plastic Surgeon.
- 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. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01125137
|United States, Michigan|
|Henry Ford Hospital Dermatology Dept. 3031 West Grand Blvd, Suite 800|
|Detroit, Michigan, United States, 48202|
|Principal Investigator:||Iltefat Hamzavi, M.D.||Henry Ford Hospital|