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CompletedNCT01125137Updated Apr 30, 2024

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

An interventional study of Removal of Keloid in Keloid, sponsored by Henry Ford Health System. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-30.

Sponsored by Henry Ford Health System · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Keloid

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Keywords

  • Keloid
  • MMP
  • Matrix metalloproteinase
  • dermatology
03

In context

Keloid

138 studies on the registry are indexed under Keloid; 26 are open to participants now.

This study's planned enrollment of 20 is below the median of 30 across 109 interventional studies indexed under Keloid.

Browse Keloid studies →

Lead sponsor

Henry Ford Health System is the lead sponsor of 303 studies on the registry; 50 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 26 (70%) have results posted.

Browse Henry Ford Health System studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form;
    4. Agree to follow and undergo all study-related procedures

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Biopsy

    Procedure: Removal of Keloid

Interventions

  • ProcedureRemoval of Keloid

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

06

What researchers measure

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.

07

Study locations

1 site
  • Henry Ford Hospital Dermatology Dept. 3031 West Grand Blvd, Suite 800
    Detroit, Michigan 48202, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2010, a primary completion of Jan 2011 and a completion of Jan 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 2, 2010
First posted
May 18, 2010
Start
Feb 2010
Primary completionActual
Jan 2011
CompletionActual
Jan 2011
Last update
Apr 30, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01125137
Lead sponsor
Henry Ford Health System
Responsible party
Iltefat Hamzavi (Dermatologist, Henry Ford Health System) — Principal investigator
First posted
May 18, 2010
Start date
Feb 2010
Primary completion
Jan 2011
Completion
Jan 2011
Last update
Apr 30, 2024

Study contacts

Iltefat Hamzavi, M.D.
principal investigator · Henry Ford Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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