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PAI-1 Expression in Non-scarring Hair Loss

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02548689
Recruitment Status : Recruiting
First Posted : September 14, 2015
Last Update Posted : January 23, 2018
Information provided by (Responsible Party):
Maria Colavincenzo, Northwestern University

Brief Summary:
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.

Condition or disease
Androgenetic Alopecia Telogen Effluvium Alopecia Areata

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.

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Study Type : Observational
Estimated Enrollment : 55 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Evaluating PAI-1 Expression in the Hair Follicles of Patients With Non-scarring Hair Loss.
Study Start Date : July 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

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.
Age-matched controls who do not have a history of hair loss and have normal scalp skin without evidence of hair loss.

Primary Outcome Measures :
  1. 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.

Biospecimen Retention:   Samples With DNA
Skin tissue will be formalin-fixed overnight at room temperature, processed and paraffin embedded. Six micron thick sections will be prepared. Tissue blocks and slides will be stored at room temperature. All samples will be de-identified.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02548689

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Contact: Yasmeen Ali 312-503-5906

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United States, Illinois
Northwestern University Department of Dermatology Recruiting
Chicago, Illinois, United States, 60611
Contact: Yasmeen Ali    312-503-5906   
Principal Investigator: Maria Colavincenzo, MD         
Sub-Investigator: Douglas Vaughan, MD         
Sub-Investigator: Ekaterina Klyachko, PhD         
Sub-Investigator: Sheila Murphy         
Sponsors and Collaborators
Northwestern University
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Principal Investigator: Maria Colavincenzo, MD Northwestern University Feinberg School of Medicine


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Responsible Party: Maria Colavincenzo, Assistant Professor in Dermatology, Northwestern University Identifier: NCT02548689     History of Changes
Other Study ID Numbers: STU00103009
First Posted: September 14, 2015    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Keywords provided by Maria Colavincenzo, Northwestern University:
hair loss
Additional relevant MeSH terms:
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Alopecia Areata
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical