Serum Ferroptosis Biomarkers (GPX4, MDA) in Alopecia Areata

NCT07733063 | Recruiting

• 1 other identifier: IEAH-DERM-2026-AA
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alopecia Areata(AA); Alopecia Areata; Alopecia Areata (& Ophiasis); Alopecia

Keywords

ferroptosis; alopecia areata; GPX4; MDA

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline

• 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

  Baseline

Secondary Outcomes (2)

• Correlation With Clinical Severity (SALT Score)

  Baseline

• Correlation With Trichoscopic Activity Findings

  Baseline

Study Arms (3)

Acute Alopecia Areata

Patients aged 18-65 formally diagnosed with Alopecia Areata, presenting with active hair loss or new patch formations within the last 6 months.

Chronic Alopecia Areata

Patients aged 18-65 formally diagnosed with Alopecia Areata, presenting with stable hair loss patches for at least 6 months with no signs of active shedding.

Healthy Controls

Age- and sex-matched healthy volunteers with no personal or family history of alopecia, and no active systemic inflammatory, metabolic, or autoimmune conditions.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Istanbul Training and Research Hospital: lead

Study Sites (1)

Istanbul Training and Research Hospital, Department of Dermatology

Istanbul, Cerrahpasa Mahallesi, 34098, Turkey (Türkiye)

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples will be separated from peripheral blood and stored at -80°C for quantitative ELISA analysis

MeSH Terms

Conditions

Alopecia Areata; Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Vildan Manav, MD

  Istanbul Training and Research Hospital

  STUDY CHAIR

Central Study Contacts

Esra Selin Kaya, MD

CONTACT

+905330257301; kayaeselin@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 29, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)