PAI-1 Expression in Non-scarring Hair Loss

NCT02548689 | Terminated

• 1 other identifier: STU00103009
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Androgenetic Alopecia; Telogen Effluvium; Alopecia Areata

Keywords

alopecia; hair loss

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Department of Dermatology

Chicago, Illinois, 60611, United States

Location

Related Publications (23)

• Norwood OT. Incidence of female androgenetic alopecia (female pattern alopecia). Dermatol Surg. 2001 Jan;27(1):53-4.

  PMID: 11231244 BACKGROUND

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

  PMID: 18627703 BACKGROUND

• Cash TF. The psychological effects of androgenetic alopecia in men. J Am Acad Dermatol. 1992 Jun;26(6):926-31. doi: 10.1016/0190-9622(92)70134-2.

  PMID: 1607410 BACKGROUND

• Cash TF, Price VH, Savin RC. Psychological effects of androgenetic alopecia on women: comparisons with balding men and with female control subjects. J Am Acad Dermatol. 1993 Oct;29(4):568-75. doi: 10.1016/0190-9622(93)70223-g.

  PMID: 8408792 BACKGROUND

• Ogunmakin KO, Rashid RM. Alopecia: the case for medical necessity. Skinmed. 2011 Mar-Apr;9(2):79-84.

  PMID: 21548511 BACKGROUND

• 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.

  PMID: 18793935 BACKGROUND

• Mounsey AL, Reed SW. Diagnosing and treating hair loss. Am Fam Physician. 2009 Aug 15;80(4):356-62.

  PMID: 19678603 BACKGROUND

• Rathnayake D, Sinclair R. Male androgenetic alopecia. Expert Opin Pharmacother. 2010 Jun;11(8):1295-304. doi: 10.1517/14656561003752730.

  PMID: 20426708 BACKGROUND

• 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. doi: 10.2174/187221312800166859.

  PMID: 22409453 BACKGROUND

• Schweiger ES, Boychenko O, Bernstein RM. Update on the pathogenesis, genetics and medical treatment of patterned hair loss. J Drugs Dermatol. 2010 Nov;9(11):1412-9.

  PMID: 21061765 BACKGROUND

• 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.

  PMID: 20956649 BACKGROUND

• Berkenpas MB, Lawrence DA, Ginsburg D. Molecular evolution of plasminogen activator inhibitor-1 functional stability. EMBO J. 1995 Jul 3;14(13):2969-77. doi: 10.1002/j.1460-2075.1995.tb07299.x.

  PMID: 7621813 BACKGROUND

• Eren M, Gleaves LA, Atkinson JB, King LE, Declerck PJ, Vaughan DE. Reactive site-dependent phenotypic alterations in plasminogen activator inhibitor-1 transgenic mice. J Thromb Haemost. 2007 Jul;5(7):1500-8. doi: 10.1111/j.1538-7836.2007.02587.x. Epub 2007 Apr 16.

  PMID: 17439629 BACKGROUND

• Bahta AW, Farjo N, Farjo B, Philpott MP. Premature senescence of balding dermal papilla cells in vitro is associated with p16(INK4a) expression. J Invest Dermatol. 2008 May;128(5):1088-94. doi: 10.1038/sj.jid.5701147. Epub 2007 Nov 8.

  PMID: 17989730 BACKGROUND

• 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. doi: 10.1111/j.1365-2133.2004.05881.x.

  PMID: 15149507 BACKGROUND

• Trueb RM. Oxidative stress in ageing of hair. Int J Trichology. 2009 Jan;1(1):6-14. doi: 10.4103/0974-7753.51923.

  PMID: 20805969 BACKGROUND

• Balsara RD, Castellino FJ, Ploplis VA. A novel function of plasminogen activator inhibitor-1 in modulation of the AKT pathway in wild-type and plasminogen activator inhibitor-1-deficient endothelial cells. J Biol Chem. 2006 Aug 11;281(32):22527-36. doi: 10.1074/jbc.M512819200. Epub 2006 Jun 19.

  PMID: 16785241 BACKGROUND

• Kortlever RM, Higgins PJ, Bernards R. Plasminogen activator inhibitor-1 is a critical downstream target of p53 in the induction of replicative senescence. Nat Cell Biol. 2006 Aug;8(8):877-84. doi: 10.1038/ncb1448. Epub 2006 Jul 23.

  PMID: 16862142 BACKGROUND

• Ploplis VA, Balsara R, Sandoval-Cooper MJ, Yin ZJ, Batten J, Modi N, Gadoua D, Donahue D, Martin JA, Castellino FJ. Enhanced in vitro proliferation of aortic endothelial cells from plasminogen activator inhibitor-1-deficient mice. J Biol Chem. 2004 Feb 13;279(7):6143-51. doi: 10.1074/jbc.M307297200. Epub 2003 Nov 18.

  PMID: 14625301 BACKGROUND

• 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. doi: 10.1055/s-2002-36699.

  PMID: 12536348 BACKGROUND

• Vaughan DE. PAI-1 antagonists: the promise and the peril. Trans Am Clin Climatol Assoc. 2011;122:312-25.

  PMID: 21686234 BACKGROUND

• Vaughan DE, De Taeye BM, Eren M. PAI-1 antagonists: predictable indications and unconventional applications. Curr Drug Targets. 2007 Sep;8(9):962-70. doi: 10.2174/138945007781662364.

  PMID: 17896947 BACKGROUND

• Angleton P, Chandler WL, Schmer G. Diurnal variation of tissue-type plasminogen activator and its rapid inhibitor (PAI-1). Circulation. 1989 Jan;79(1):101-6. doi: 10.1161/01.cir.79.1.101.

  PMID: 2491971 BACKGROUND

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.

MeSH Terms

Conditions

Alopecia; Alopecia Areata

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Maria Colavincenzo, MD

  Northwestern University Feinberg School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Dermatology

Study Record Dates

• First Submitted: August 3, 2015
• First Posted: September 14, 2015
• Study Start: July 1, 2015
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: June 9, 2022

Record last verified: 2022-06

Locations

US (1)