Alopecia Areata(AA)NCT07733063
Serum Ferroptosis Biomarkers (GPX4, MDA) in Alopecia Areata
An observational study of Alopecia Areata(AA) and Alopecia Areata, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alopecia Areata(AA), Alopecia Areata, Alopecia Areata (& Ophiasis)
- How many people
- 156 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2026to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Training and Research Hospital, Department of Dermatology
Istanbul, Cerrahpasa Mahallesi, 34098
Esra Selin Kaya, MD, +905330257301, kayaeselin@gmail.com
Vildan Manav, MD, +905334323524, drvildanmanav@gmail.com
About this study
Official 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
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.
- Keywords
- ferroptosis, alopecia areata, GPX4, MDA
- Medical subject headings
- Alopecia Areata, Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Baseline
Secondary outcomes (2)
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).
Measured: Baseline
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start1 Jun 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia Areata(AA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Esra Selin Kaya, Istanbul Training and Research Hospital
- Investigators
- Vildan Manav, MD, Study chair, Istanbul Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07733063
- Sponsor's protocol ID
- IEAH-DERM-2026-AA
- Status last verified
- Jul 2026
- First submitted
- 25 Jun 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared externally due to institutional data privacy regulations and ethical committee restrictions regarding patient confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07733063
- Acronym / sponsor ID
- IEAH-DERM-2026-AA
- Keywords
- ferroptosis, alopecia areata, GPX4, MDA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Istanbul Training and Research HospitalOther government
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
2 secondary outcomes
Correlation With Clinical Severity (SALT Score)
Time frame: Baseline
Correlation With Trichoscopic Activity Findings
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared externally due to institutional data privacy regulations and ethical committee restrictions regarding patient confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vildan Manav, MD study chair
Istanbul Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alopecia Areata(AA) and Alopecia Areata, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esra Selin Kaya, MD (+905330257301, kayaeselin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum GPX4 Levels (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.