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Completed

NCT Number: NCT01125137

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henry Ford Hospital Dermatology Dept. 3031 West Grand Blvd, Suite 800

Detroit, Michigan, 48202, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Removal of Keloid

Procedure

Keloid will be excised by Henry Ford Hospital Dermatologist, Dermatosurgeon or Plastic Surgeon.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 18, 2010
Registry last updated
Apr 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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