PAI-1 Expression in Non-scarring Hair Loss

June 7, 2022 updated by: Maria Colavincenzo, Northwestern University

Evaluating PAI-1 Expression in the Hair Follicles of Patients With Non-scarring Hair Loss.

This study will investigate whether subjects who suffer from hair loss have increased levels of PAI-1 compared to age-matched control subjects. The level of PAI-1 expression will be determined in subjects without hair loss and in subjects with non-scarring hair loss, including androgenetic alopecia, telogen effluvium and alopecia areata.

Study Overview

Status

Terminated

Conditions

Detailed Description

This study will compare the levels of PAI-1 expression in subjects with different forms of non-scarring hair loss and in these subjects vs normal age-matched controls. Hair loss subjects will have their Northwestern Memorial Hospital and Northwestern Medical Faculty Foundation medical records reviewed to ensure they meet inclusion and exclusion criteria. All subjects will have a 4 mm punch biopsy on the scalp. Tissue PAI-1 levels from scalp skin biopsies will be determined by immunohistochemical staining. Samples will be kept for approximately 15 years, after which time unused samples will be destroyed.

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Department of Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All hair loss subjects will be recruited from patients seen at Northwestern Memorial Hospital or Northwestern Medical Faculty Foundation physicians offices. Age-matched control subjects will be recruited by either 1) the use of flyers displayed in the hospital and surrounding community, or 2) will be identified during a clinic visit at Northwestern Memorial Hospital or Northwestern Medical Faculty Foundation physician offices.

Description

Inclusion Criteria:

  • Age-matched control subjects who do not have a history of hair loss
  • A clinical and pathologic diagnosis of androgenetic alopecia, telogen effluvium, alopecia areata or normal scalp skin
  • All subjects must have given signed, informed consent prior to registration in study

Exclusion Criteria:

  • History of previous hair transplantation
  • Current and past use of medications topically on the scalp
  • Clinical or pathologic diagnosis of a scarring alopecia
  • History of inflammatory conditions of the scalp such as psoriasis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Non-scarring hair loss
Patients seen at Northwestern Memorial Hospital or Northwestern Medical Faculty Foundation physician offices that have undergone evaluation for hair loss and have a diagnosis of androgenetic alopecia, telogen effluvium or alopecia areata.
Control
Age-matched controls who do not have a history of hair loss and have normal scalp skin without evidence of hair loss.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PAI-1 expression level in scalp skin biopsy samples
Time Frame: Baseline
Tissue PAI-1 expression levels will be determined by immunohistochemistry, a three-layer biotin-strepavidin system. Positive PAI-1 expression per total tissue area will be quantified using the color-picker function in imaging software.The PAI-1 expression found in normal scalps will be compared to those found in scalps with hair loss.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

  • Principal Investigator: Maria Colavincenzo, MD, Northwestern University Feinberg School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

June 1, 2021

Study Completion (Actual)

June 1, 2021

Study Registration Dates

First Submitted

August 3, 2015

First Submitted That Met QC Criteria

September 10, 2015

First Posted (Estimate)

September 14, 2015

Study Record Updates

Last Update Posted (Actual)

June 9, 2022

Last Update Submitted That Met QC Criteria

June 7, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00103009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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