Serum Ferroptosis Biomarkers (GPX4, MDA) in Alopecia Areata
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorIstanbul Training and Research Hospital
About this trial
This study aims to investigate the potential role of the ferroptosis pathway in the pathogenesis and clinical course of Alopecia Areata (AA). Serum concentrations of two key ferroptosis biomarkers-Glutathione Peroxidase 4 (GPX4), a primary antioxidant enzyme protecting against lipid peroxidation, and Malondialdehyde (MDA), a major end-product of lipid membrane damage-will be quantitatively measured using Enzyme-Linked Immunosorbent Assay (ELISA) kits.
A total of 156 participants will be enrolled, consisting of 104 patients diagnosed with Alopecia Areata (subdivided into acute and chronic cohorts) and 52 age- and sex-matched healthy controls. Serum biomarker levels will be statistically compared among the groups to determine their diagnostic value. Furthermore, these biomarker levels will be correlated with clinical disease extension evaluated via the Severity of Alopecia Tool (SALT) score and objective trichoscopic activity findings (such as black dots, yellow dots, and exclamation mark hairs). The ultimate goal of this cross-sectional study is to evaluate whether serum GPX4 and MDA can serve as reliable objective biomarkers for monitoring disease severity, staging, and trichoscopic activity in Alopecia Areata management.The ultimate goal of this cross-sectional study is to evaluate whether serum GPX4 and MDA can serve as reliable objective biomarkers for monitoring disease severity, staging, and trichoscopic activity in Alopecia Areata management.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients aged between 18 and 65 years.
Formally diagnosed with Alopecia Areata based on clinical and trichoscopic examination.
Healthy volunteers with no personal or family history of alopecia or any systemic inflammatory/autoimmune conditions (for the healthy control group).
Patients who have provided written informed consent before any study-related procedures.
Disqualifiers
Use of topical corticosteroids, intralesional steroid injections, or topical calcineurin inhibitors within the last 1 month.
Use of systemic immunosuppressive therapies, systemic corticosteroids, or JAK inhibitors within the last 3 months.
Presence of any other co-existing active autoimmune or inflammatory skin diseases (e.g., Psoriasis, Vitiligo, or active autoimmune thyroiditis with elevated TSH levels).
History of malignancy, active severe infection, chronic hepatic failure, or chronic renal failure.
Trial population
The study population will be selected from patients who present to the Department of Dermatology at Istanbul Training and Research Hospital and meet all the eligibility criteria. The sample will consist of two primary groups: a patient group diagnosed with Alopecia Areata (further stratified into acute and chronic cohorts based on disease activity and duration) and an age- and sex-matched healthy control group comprised of volunteers with no prior history of alopecia or systemic disease.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
156 Participants
are grouped into 3 trial groupsGroup A: Acute Alopecia Areata
Group B: Chronic Alopecia Areata
Group C: Healthy Controls
Trial outcomes
Primary outcomes
1
Serum GPX4 Levels
Quantitative measurement of serum Glutathione Peroxidase 4 (GPX4) concentrations (expressed in ng/mL) via Enzyme-Linked Immunosorbent Assay (ELISA) to evaluate the systemic activity of the ferroptosis pathway.
Time frame
Baseline2
Serum Malondialdehyde (MDA) levels
Quantitative measurement of serum Malondialdehyde (MDA) concentrations (expressed in ng/mL) via Enzyme-Linked Immunosorbent Assay (ELISA) to evaluate the systemic activity of the ferroptosis pathway
Time frame
BaselineSecondary outcomes
1
Correlation With Clinical Severity (SALT Score)
Evaluation of the statistical correlation between serum ferroptosis biomarker levels (GPX4 and MDA) and the clinical extent of hair loss, scored objectively using the Severity of Alopecia Tool (SALT score, which ranges from 0% to 100%, where higher percentages indicate more severe hair loss).
Time frame
Baseline2
Correlation With Trichoscopic Activity Findings
Evaluation of the statistical relationship between serum ferroptosis biomarker levels (GPX4 and MDA) and the presence or count of objective trichoscopic signs of disease activity-specifically black dots, yellow dots, exclamation mark hairs, broken hairs, and cadaverous hairs-observed during dermoscopic examination of the scalp lesions.
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov