Evaluation of Serum Ferroptosis Biomarkers (GPX4 and MDA) and Their Relationship With Disease Stage, Clinical Severity, and Trichoscopic Findings in Patients With Alopecia Areata
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Serum GPX4 and MDA Levels
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
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.
结局指标
主要结局
Serum GPX4 and MDA Levels
时间窗: Baseline
Quantitative measurement of serum Glutathione Peroxidase 4 (GPX4) concentrations (expressed in ng/mL) and Malondialdehyde (MDA) concentrations (expressed in ng/mL) via Enzyme-Linked Immunosorbent Assay (ELISA) to evaluate the systemic activity of the ferroptosis pathway.
Serum GPX4 Levels
时间窗: 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.
Serum Malondialdehyde (MDA) levels
时间窗: 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
次要结局
- Correlation With Clinical Severity (SALT Score)(Baseline)
- Correlation With Trichoscopic Activity Findings(Baseline)
研究者
Esra Selin Kaya
Principle Investigator
Istanbul Training and Research Hospital