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NCT Number: NCT07733063

Serum Ferroptosis Biomarkers (GPX4, MDA) in Alopecia Areata

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.

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Key information

Conditions

Alopecia Areata(AA) Alopecia Alopecia Areata Alopecia Areata (& Ophiasis) Hair Diseases Hypotrichosis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Pregnancy or lactation.
  • History of heavy smoking or uncontrolled/regular use of antioxidant or vitamin supplements (e.g., Vitamin E, Vitamin C, CoQ10, NMN, resveratrol).

Treatment and study plan

Primary outcomes

  1. Serum GPX4 Levels

    Time frame: Baseline

    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.

  2. Serum Malondialdehyde (MDA) levels

    Time frame: Baseline

    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

Secondary outcomes

  1. Correlation With Clinical Severity (SALT Score)

    Time frame: Baseline

    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).

  2. Correlation With Trichoscopic Activity Findings

    Time frame: Baseline

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Esra Selin Kaya, MD

CONTACT

[email protected]

+905330257301

Sponsors and collaborators

Lead sponsor

Istanbul Training and Research Hospital

Other Gov

Registry information

Official study title

Evaluation of Serum Ferroptosis Biomarkers (GPX4 and MDA) and Their Relationship With Disease Stage, Clinical Severity, and Trichoscopic Findings in Patients With Alopecia Areata

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jul 29, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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