NCT01125137

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 2, 2010

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 18, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

April 30, 2024

Status Verified

April 1, 2024

Enrollment Period

11 months

First QC Date

February 2, 2010

Last Update Submit

April 29, 2024

Conditions

Keywords

KeloidMMPMatrix metalloproteinasedermatology

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (1)

Biopsy

EXPERIMENTAL
Procedure: Removal of Keloid

Interventions

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

Biopsy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Keloid

Condition Hierarchy (Ancestors)

Collagen DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesCicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Iltefat Hamzavi, M.D.

    Henry Ford Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dermatologist

Study Record Dates

First Submitted

February 2, 2010

First Posted

May 18, 2010

Study Start

February 1, 2010

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

April 30, 2024

Record last verified: 2024-04

Locations