Association of TLR7 Gene rs3853839 Polymorphism With Disease Severity in Alopecia Areata: A Case-Control Study (TLR7-AA)

March 2, 2026 updated by: karem Taha ibrahim khalil, Benha University

Association Between Toll Like Receptor- 7 Gene Polymorphism and Alopecia Areata

Alopecia areata is an autoimmune, non-scarring hair loss disorder characterized by variable clinical severity. Toll-like receptor 7 (TLR7) plays a key role in innate immune activation and autoimmune responses. The rs3853839 polymorphism of the TLR7 gene has been implicated in immune-mediated diseases. This study aims to evaluate the association between TLR7 rs3853839 polymorphism and susceptibility to alopecia areata, and to assess its correlation with disease severity measured by the Severity of Alopecia Tool (SALT) score.

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Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Qalyubia Governorate
      • Banhā, Qalyubia Governorate, Egypt, 13511
        • Principal Investigator

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study includes 60 patients clinically diagnosed with alopecia areata and 60 age- and sex-matched healthy controls recruited from the same geographic region.

Description

Inclusion Criteria (Cases):

  • Clinical diagnosis of alopecia areata
  • Age ≥ 18 years
  • Both genders
  • Provision of written informed consent

Inclusion Criteria (Controls):

  • Apparently healthy individuals
  • No personal or family history of autoimmune disease
  • Age- and sex-matched to patient group
  • Provision of written informed consent

Exclusion Criteria:

  • Presence of other autoimmune or inflammatory disorders
  • Current systemic immunosuppressive therapy
  • Pregnancy or lactation
  • Refusal to participate

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Alopecia Areata Patients
Sixty patients diagnosed clinically with alopecia areata. Peripheral blood samples will be collected for DNA extraction and genotyping of TLR7 rs3853839 polymorphism. Disease severity will be assessed using the SALT score.
Healthy Controls
Sixty age- and sex-matched healthy individuals without autoimmune disease. Peripheral blood samples will be collected for DNA extraction and genotyping of TLR7 rs3853839 polymorphism.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genotype and Allele Frequency Distribution of TLR7 rs3853839
Time Frame: Baseline
Comparison of genotype and allele frequencies of TLR7 rs3853839 polymorphism between alopecia areata patients and healthy controls.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association Between TLR7 rs3853839 Polymorphism and Disease Severity
Time Frame: Baseline
Evaluation of the correlation between TLR7 rs3853839 genotypes and Severity of Alopecia Tool (SALT) score among alopecia areata patients.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Actual)

December 10, 2023

Study Completion (Actual)

December 12, 2023

Study Registration Dates

First Submitted

March 2, 2026

First Submitted That Met QC Criteria

March 2, 2026

First Posted (Actual)

March 6, 2026

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

March 2, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS 44-11-2022 (Registry Identifier: BENHA UNIVESITY FACULTY OF MEICINE)
  • FAULTY OF MEDICINE BENHA (Other Identifier: MS 44-11-2022)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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