Androgenetic AlopeciaNCT02548689
PAI-1 Expression in Non-scarring Hair Loss
An observational study of Androgenetic Alopecia and Telogen Effluvium, run by Northwestern University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Androgenetic Alopecia, Telogen Effluvium, Alopecia Areata
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Department of Dermatology
Chicago, Illinois, 60611
About this study
Official title: 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.
Read the 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.
- Conditions
- Androgenetic Alopecia, Telogen Effluvium, Alopecia Areata
- Keywords
- alopecia, hair loss
- Medical subject headings
- Alopecia, Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2015 (estimated)
- Study startJul 2015
- Primary completionJun 2021
- Study completionJun 2021
Why it stopped: Original lead investigator left Northwestern University
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Androgenetic AlopeciaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Colavincenzo, Northwestern University
- Investigators
- Maria Colavincenzo, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02548689
- Sponsor's protocol ID
- STU00103009
- Status last verified
- Jun 2022
- First submitted
- 3 Aug 2015
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Norwood OT. Incidence of female androgenetic alopecia (female pattern alopecia). Dermatol Surg. 2001 Jan;27(1):53-4.
PubMed 11231244Scheinfeld N. A review of hormonal therapy for female pattern (androgenic) alopecia. Dermatol Online J. 2008 Mar 15;14(3):1.
PubMed 18627703Cash 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.
PubMed 1607410Cash 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.
PubMed 8408792Ogunmakin KO, Rashid RM. Alopecia: the case for medical necessity. Skinmed. 2011 Mar-Apr;9(2):79-84.
PubMed 21548511Rogers 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.
PubMed 18793935Mounsey AL, Reed SW. Diagnosing and treating hair loss. Am Fam Physician. 2009 Aug 15;80(4):356-62.
PubMed 19678603Rathnayake D, Sinclair R. Male androgenetic alopecia. Expert Opin Pharmacother. 2010 Jun;11(8):1295-304. doi: 10.1517/14656561003752730.
PubMed 20426708Rossi 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.
PubMed 22409453Schweiger 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.
PubMed 21061765Mella 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.
PubMed 20956649Berkenpas 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.
PubMed 7621813Eren 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.
PubMed 17439629Bahta 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.
PubMed 17989730Simonetti 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.
PubMed 15149507
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating PAI-1 Expression in the Hair Follicles of Patients With Non-scarring Hair Loss.
- ClinicalTrials.gov ID
- NCT02548689
- Acronym / sponsor ID
- STU00103009
- Conditions
- Androgenetic Alopecia, Telogen Effluvium, Alopecia Areata
- Keywords
- alopecia, hair loss
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Original lead investigator left Northwestern University
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jun 2021 (actual)
- Study completion
- Jun 2021 (actual)
- First posted
- 14 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study was stopped early (reason given: Original lead investigator left Northwestern University). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Background: PubMed 11231244Norwood OT. Incidence of female androgenetic alopecia (female pattern alopecia). Dermatol Surg. 2001 Jan;27(1):53-4.
- Background: PubMed 18627703Scheinfeld N. A review of hormonal therapy for female pattern (androgenic) alopecia. Dermatol Online J. 2008 Mar 15;14(3):1.
- Background: PubMed 1607410Cash 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.
- Background: PubMed 8408792Cash 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.
- Background: PubMed 21548511Ogunmakin KO, Rashid RM. Alopecia: the case for medical necessity. Skinmed. 2011 Mar-Apr;9(2):79-84.
- Background: PubMed 18793935Rogers 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.
- Background: PubMed 19678603Mounsey AL, Reed SW. Diagnosing and treating hair loss. Am Fam Physician. 2009 Aug 15;80(4):356-62.
- Background: PubMed 20426708Rathnayake D, Sinclair R. Male androgenetic alopecia. Expert Opin Pharmacother. 2010 Jun;11(8):1295-304. doi: 10.1517/14656561003752730.
- Background: PubMed 22409453Rossi 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.
- Background: PubMed 21061765Schweiger 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.
- Background: PubMed 20956649Mella 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.
- Background: PubMed 7621813Berkenpas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Colavincenzo, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Androgenetic Alopecia and Telogen Effluvium, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Original lead investigator left Northwestern University). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PAI-1 expression level in scalp skin biopsy samples (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02548689, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2022.