PAI-1 Expression in Non-scarring Hair Loss

Alopecia Areata Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02548689
• Other study ID #: STU00103009
• Status: Terminated
• Start date: July 2015
• Est. completion date: June 2021

Study information

• Verified date: June 2022
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Androgenetic Alopecia
• Telogen Effluvium

Locations

Country	Name	City	State
United States	Northwestern University Department of Dermatology	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (23)

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Mella JM, Perret MC, Manzotti M, Catalano HN, Guyatt G. Efficacy and safety of finasteride therapy for androgenetic alopecia: a systematic review. Arch Dermatol. 2010 Oct;146(10):1141-50. doi: 10.1001/archdermatol.2010.256. Review. — View Citation

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Rogers NE, Avram MR. Medical treatments for male and female pattern hair loss. J Am Acad Dermatol. 2008 Oct;59(4):547-66; quiz 567-8. doi: 10.1016/j.jaad.2008.07.001. Review. — View Citation

Rossi A, Cantisani C, Melis L, Iorio A, Scali E, Calvieri S. Minoxidil use in dermatology, side effects and recent patents. Recent Pat Inflamm Allergy Drug Discov. 2012 May;6(2):130-6. Review. — View Citation

Scheinfeld N. A review of hormonal therapy for female pattern (androgenic) alopecia. Dermatol Online J. 2008 Mar 15;14(3):1. Review. — View Citation

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Simonetti O, Lucarini G, Bernardini ML, Simoncini C, Biagini G, Offidani A. Expression of vascular endothelial growth factor, apoptosis inhibitors (survivin and p16) and CCL27 in alopecia areata before and after diphencyprone treatment: an immunohistochemical study. Br J Dermatol. 2004 May;150(5):940-8. — View Citation

Takeshita K, Yamamoto K, Ito M, Kondo T, Matsushita T, Hirai M, Kojima T, Nishimura M, Nabeshima Y, Loskutoff DJ, Saito H, Murohara T. Increased expression of plasminogen activator inhibitor-1 with fibrin deposition in a murine model of aging, "Klotho" mouse. Semin Thromb Hemost. 2002 Dec;28(6):545-54. — View Citation

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* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PAI-1 expression level in scalp skin biopsy samples	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