- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07499713
Association of Serum VEGF-A and VCAM-1 Levels With Nailfold Capilleroscopic Alterations in Alopecia Areata
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.
Study Overview
Status
Detailed Description
Alopecia areata (AA) is a common autoimmune form of non-scarring hair loss. Although the exact cause is unknown, it is thought that inflammation and changes in the microvasculature (small blood vessels) play a significant role. This study aims to investigate the systemic and local vascular components of the disease.
The study includes 60 patients diagnosed with alopecia areata and 30 age- and sex-matched healthy volunteers. Patients are categorized into two groups based on disease duration:
Acute Group: Patients with a disease duration of less than 6 months.
Chronic Group: Patients with a disease duration of 6 months or longer.
Methodology and Procedures:
Dermatological and Trichoscopic Examination: All patients undergo a clinical examination using a Dermlite 5 dermatoscope. The severity of hair loss is calculated using the SALT (Severity of Alopecia Tool) score. Trichoscopic markers of disease activity, including black dots, yellow dots, exclamation mark hairs, broken hairs, vellus hairs, and pigtail hairs, are recorded according to Rudnicka's criteria.
Nailfold Capillaroscopy: To evaluate local microvascular alterations, nailfold capillaroscopy is performed using a Dino-Lite digital microscope (50x magnification). Examinations are conducted on the 2nd to 5th fingers of both hands after a 15-minute acclimatization period in a temperature-controlled room (20-23 °C). Morphological changes such as capillary dilatation, tortuosity, hemorrhages, and avascular areas are documented. An "abnormal pattern" is defined as the presence of two or more abnormalities in at least two fingers.
Biochemical Analysis: Venous blood samples are collected from all participants. After centrifugation, serum is separated and stored at -80 °C. Serum levels of Vascular Endothelial Growth Factor A (VEGF-A) and Vascular Cell Adhesion Molecule 1 (VCAM-1) are measured using the ELISA method.
The study will analyze the correlation between these biochemical markers, trichoscopic activity signs, and capillaroscopic findings to better understand the vascular pathogenesis of alopecia areata across different disease stages.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey (Türkiye)
- Istanbul Education and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Acute alopecia areata patients
Patients diagnosed with alopecia areata who have a disease duration of less than 6 months.
|
his intervention focuses on the integration of microvascular and biochemical markers to phenotype Alopecia Areata subgroups.
Other Names:
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.
Other Names:
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.
Other Names:
|
|
Chronic alopecia areata patients
Patients diagnosed with alopecia areata who have a disease duration of 6 months or longer.
|
his intervention focuses on the integration of microvascular and biochemical markers to phenotype Alopecia Areata subgroups.
Other Names:
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.
Other Names:
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.
Other Names:
|
|
Healthy Control Group
Age- and sex-matched healthy volunteers with no history of alopecia, other autoimmune disorders, or systemic inflammatory diseases.
|
his intervention focuses on the integration of microvascular and biochemical markers to phenotype Alopecia Areata subgroups.
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Serum Levels of VEGF-A and VCAM-1
Time Frame: At enrollment (Baseline - Single time point)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nailfold Capillaroscopic Patterns
Time Frame: At enrollment
|
Assessment of microvascular morphology (dilatation, tortuosity, hemorrhages) using a 50x digital microscope.
|
At enrollment
|
|
Correlation with SALT Score and Trichoscopic Signs
Time Frame: At enrollment
|
Evaluation of the relationship between serum biomarkers (VEGF-A, VCAM-1) and clinical severity (SALT score) or activity signs (exclamation mark hairs, black dots).
|
At enrollment
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathological Conditions, Anatomical
- Skin Diseases
- Hypotrichosis
- Hair Diseases
- Pathological Conditions, Signs and Symptoms
- Skin and Connective Tissue Diseases
- Alopecia Areata
- Alopecia
- Investigative Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Diagnostic Imaging
- Diagnostic Techniques, Cardiovascular
- Microscopy
- Intravital Microscopy
- Microscopic Angioscopy
- Dermoscopy
Other Study ID Numbers
- E-10840098-202.3.02-7702
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.