Alopecia AreataTLR7-AANCT07454876
Association of TLR7 Gene rs3853839 Polymorphism With Disease Severity in Alopecia Areata: A Case-Control Study
An observational study of Alopecia Areata and TLRs, run by Benha University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alopecia Areata, TLRs
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2022to 12 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Clinical diagnosis of alopecia areata
- Age ≥ 18 years
- Both genders
- Provision of written informed consent
- Apparently healthy individuals
- No personal or family history of autoimmune disease
- Age- and sex-matched to patient group
- Provision of written informed consent
Who cannot join
- Presence of other autoimmune or inflammatory disorders
- Current systemic immunosuppressive therapy
- Pregnancy or lactation
- Refusal to participate
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
________________________________________
- Conditions
- Alopecia Areata, TLRs
- Keywords
- Alopecia Areata, TLR7, rs3853839
- Medical subject headings
- Alopecia Areata
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 |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Genotype and Allele Frequency Distribution of TLR7 rs3853839
Comparison of genotype and allele frequencies of TLR7 rs3853839 polymorphism between alopecia areata patients and healthy controls.
Measured: Baseline
Secondary outcomes (1)
Association Between TLR7 rs3853839 Polymorphism and Disease Severity
Evaluation of the correlation between TLR7 rs3853839 genotypes and Severity of Alopecia Tool (SALT) score among alopecia areata patients.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start1 Dec 2022
- Primary completion10 Dec 2023
- Study completion12 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, karem Taha ibrahim khalil, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07454876
- Sponsor's protocol ID
- MS 44-11-2022
- Other IDs
- MS 44-11-2022, FAULTY OF MEDICINE BENHA
- Acronym
- TLR7-AA
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ho CY, Wu CY, Chen JY, Wu CY. Clinical and Genetic Aspects of Alopecia Areata: A Cutting Edge Review. Genes (Basel). 2023 Jun 28;14(7):1362. doi: 10.3390/genes14071362.
PubMed 37510267
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Toll Like Receptor- 7 Gene Polymorphism and Alopecia Areata
- ClinicalTrials.gov ID
- NCT07454876
- Acronym / sponsor ID
- TLR7-AA / MS 44-11-2022
- Conditions
- Alopecia Areata, TLRs
- Keywords
- Alopecia Areata, TLR7, rs3853839
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 10 Dec 2023 (actual)
- Study completion
- 12 Dec 2023 (actual)
- First posted
- 6 Mar 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.
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.
________________________________________
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- Clinical diagnosis of alopecia areata
- Age ≥ 18 years
- Both genders
- Provision of written informed consent
- Apparently healthy individuals
Key exclusion criteria (5 listed)
- Presence of other autoimmune or inflammatory disorders
- Current systemic immunosuppressive therapy
- Pregnancy or lactation
- Refusal to participate
- -
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
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.
1 secondary outcome
Association Between TLR7 rs3853839 Polymorphism and Disease Severity
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Results publication: PubMed 37510267Ho CY, Wu CY, Chen JY, Wu CY. Clinical and Genetic Aspects of Alopecia Areata: A Cutting Edge Review. Genes (Basel). 2023 Jun 28;14(7):1362. doi: 10.3390/genes14071362.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 and TLRs, run by Benha University at 1 site in Egypt.
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 8 inclusion and 5 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: finished, as of the sponsor's last update on 6 Mar 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genotype and Allele Frequency Distribution of TLR7 rs3853839 (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07454876, which also lists 1 linked publication.
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 6 Mar 2026.