NCT07499713

Brief Summary

The goal of this observational study is to learn about microvascular changes and hair follicle activity in patients with alopecia areata. The main questions it aims to answer are: Do blood levels of markers related to blood vessel formation (VEGF-A) and inflammation (VCAM-1) differ between patients with alopecia areata and healthy individuals? Is there a link between these blood markers and structural changes in the nailfold capillaries? How do these markers relate to specific trichoscopic signs of disease activity (such as black dots or exclamation mark hairs) and the overall severity of hair loss (SALT score)? Researchers will compare patients with alopecia areata (grouped by disease duration: acute \<6 months vs. chronic \>6 months) to healthy volunteers to see if there is a significant difference in systemic and local vascular indicators. Participants will: Undergo a trichoscopic scalp examination to identify markers of disease activity (black dots, yellow dots, exclamation mark hairs) and calculate the SALT score. Have their nailfolds examined with a digital capillaroscope (50x) to detect microvascular alterations. Provide a blood sample to measure the levels of VEGF-A and VCAM-1.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
2mo left

Started Apr 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Apr 2026Jul 2026

First Submitted

Initial submission to the registry

March 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 30, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

March 24, 2026

Last Update Submit

March 24, 2026

Conditions

Keywords

alopecia areatahair lossvegf avcam 1nfcnailfold capilleroscopytrichoscopynonscarring alopecia

Outcome Measures

Primary Outcomes (1)

  • Serum Levels of VEGF-A and VCAM-1

    Serum concentrations of Vascular Endothelial Growth Factor A and Vascular Cell Adhesion Molecule 1 will be measured to evaluate systemic vascular involvement and endothelial activation in patients with Alopecia Areata.

    At enrollment (Baseline - Single time point)

Secondary Outcomes (2)

  • Nailfold Capillaroscopic Patterns

    At enrollment

  • Correlation with SALT Score and Trichoscopic Signs

    At enrollment

Study Arms (3)

Acute alopecia areata patients

Patients diagnosed with alopecia areata who have a disease duration of less than 6 months.

Diagnostic Test: Microvascular ImagingDiagnostic Test: Biochemical Biomarker AnalysisDiagnostic Test: Trichoscopic Imaging

Chronic alopecia areata patients

Patients diagnosed with alopecia areata who have a disease duration of 6 months or longer.

Diagnostic Test: Microvascular ImagingDiagnostic Test: Biochemical Biomarker AnalysisDiagnostic Test: Trichoscopic Imaging

Healthy Control Group

Age- and sex-matched healthy volunteers with no history of alopecia, other autoimmune disorders, or systemic inflammatory diseases.

Diagnostic Test: Microvascular ImagingDiagnostic Test: Biochemical Biomarker Analysis

Interventions

Microvascular ImagingDIAGNOSTIC_TEST

his intervention focuses on the integration of microvascular and biochemical markers to phenotype Alopecia Areata subgroups.

Also known as: Nailfold Capillaroscopy, NVC
Acute alopecia areata patientsChronic alopecia areata patientsHealthy Control Group

Collection of 5-10 mL venous blood samples. Serum is separated by centrifugation (3000 RPM, 10 min) and analyzed via Enzyme-Linked Immunosorbent Assay (ELISA) to determine the levels of Vascular Endothelial Growth Factor A and Vascular Cell Adhesion Molecule 1.

Also known as: Serum VEGF-A, Serum VCAM-1
Acute alopecia areata patientsChronic alopecia areata patientsHealthy Control Group
Trichoscopic ImagingDIAGNOSTIC_TEST

his non-invasive procedure focuses on identifying specific trichoscopic patterns associated with Alopecia Areata activity, including yellow dots, black dots, exclamation mark hairs, and broken hairs.

Also known as: Trichoscopy, Dermoscopy
Acute alopecia areata patientsChronic alopecia areata patients

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of patients diagnosed with Alopecia Areata (AA) and healthy volunteers recruited from Istanbul Education and Research Hospital, a tertiary care dermatology outpatient clinic in Istanbul. The patient group is stratified into acute and chronic phenotypes based on disease duration. The healthy control group includes age- and sex-matched individuals with no history of hair, nail, or systemic vascular diseases.

You may qualify if:

  • Age: Participants aged between 18 and 60 years.
  • Diagnosis: Clinical and trichoscopic diagnosis of Alopecia Areata (AA) by a dermatologist.
  • Categorization: "Acute" (\<6 months duration) or "Chronic" (≥6 months duration) groups.
  • Consent: Ability to provide written informed consent for participation in the study.

You may not qualify if:

  • Medical History: Patients with a history of diabetes mellitus, autoimmune diseases, connective tissue diseases, chronic inflammatory or vascular diseases.
  • Pregnancy \& Lactation: Pregnancy or breastfeeding.
  • Lifestyle Factors: Active smoking or chronic alcohol use.
  • Hair \& Nail Conditions: Causes of hair loss other than alopecia areata, the presence of any nail disease, or having had a manicure within the last 3 weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Education and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood samples (approximately 5-10 mL) are collected from each participant into vacuum tubes containing gel separators. After being allowed to clot at room temperature, the samples are centrifuged at 3000 rpm for 10 minutes. The separated serum is then aliquoted into Eppendorf tubes and stored at -80°C until the laboratory analysis of VEGF-A and VCAM-1 levels via ELISA is performed.

MeSH Terms

Conditions

Alopecia AreataAlopecia

Interventions

Microscopic AngioscopyDermoscopy

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Intravital MicroscopyMicroscopyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, CardiovascularInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dermatology Resident

Study Record Dates

First Submitted

March 24, 2026

First Posted

March 30, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations