VitiligoNCT07232238
TRPM2 Gene Polymorphism, NLRP3 Inflammasome Expression in Vitiligo Patients
An observational study of Vitiligo, run by Aswan University at 1 site in Egypt.
Trial summary
This study investigates the relationship between Transient Receptor Potential Melastatin 2 (TRPM2) gene polymorphism and Nucleotide-binding oligomerization domain-like receptor protein 3 (NLRP3) inflammasome expression in patients with vitiligo. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vitiligo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Oct 2025to 1 May 2027
- How long will I take part?
- 1 Day
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients with clinically diagnosed vitiligo attending the Dermatology Department at Aswan University Hospital, Egypt, and healthy control participants matched for age and sex.
Who may be able to join
- Adult patients (aged 18 years and older) clinically diagnosed with vitiligo, either newly diagnosed or not on treatment for at least 3 months before the study.
Who cannot join
- Any participant with associated inflammatory disease (such as infections or autoimmune disorders).
- Patients with chronic diseases including cardiac, hepatic, hematologic, or renal disorders, or malignancies.
- Patients who had recent major surgical procedures.
- Patients with segmental vitiligo.
- Vitiligo patients who have received treatment within 3 months prior to the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TRPM2 Gene Polymorphism in Relation to NLRP3 Inflammasome Expression in Vitiligo Patients
This study investigates the relationship between Transient Receptor Potential Melastatin 2 (TRPM2) gene polymorphism and Nucleotide-binding oligomerization domain-like receptor protein 3 (NLRP3) inflammasome expression in patients with vitiligo. Vitiligo is a common autoimmune depigmenting disorder characterized by melanocyte destruction associated with oxidative stress and immune dysregulation.
TRPM2 is a calcium-permeable cation channel activated by oxidative stress, while NLRP3 inflammasome activation promotes inflammation through interleukin-1β (IL-1β) and interleukin-18 (IL-18) release. This study aims to evaluate TRPM2 genetic variants, NLRP3 expression levels, and their possible correlation with disease severity measured using the Vitiligo Area Scoring Index (VASI).
Read the detailed description
Vitiligo is a chronic autoimmune depigmenting disorder characterized by selective loss of melanocytes. Oxidative stress plays a central role in triggering melanocyte damage. Transient Receptor Potential Melastatin 2 (TRPM2) is a calcium-permeable cation channel activated by reactive oxygen species (ROS). Activation of TRPM2 leads to increased intracellular calcium (Ca2+) influx and mitochondrial dysfunction, contributing to melanocyte apoptosis.
The Nucleotide-binding oligomerization domain-like receptor protein 3 (NLRP3) inflammasome is an intracellular multiprotein complex activated by cellular stress signals, including Ca2+ influx, ROS, and mitochondrial injury. NLRP3 activation results in caspase-1 activation and the release of pro-inflammatory cytokines interleukin-1β (IL-1β) and interleukin-18 (IL-18), which further contribute to melanocyte destruction.
Evidence suggests an interaction between TRPM2 activation and NLRP3 inflammasome signaling, particularly under oxidative stress conditions. However, this relationship has not been studied in vitiligo patients. This study investigates TRPM2 gene polymorphism, evaluates NLRP3 expression levels, and explores their association with disease presence and severity.
- Conditions
- Vitiligo
- Keywords
- TRPM2, NLRP3, oxidative stress, inflammasome, genetic polymorphism
- Medical subject headings
- Vitiligo
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 |
|---|---|---|
| Vitiligo Patients | Participants clinically diagnosed with vitiligo, recruited from the Dermatology Outpatient Clinic, Aswan University Hospital. Peripheral blood samples will be collected for TRPM2 gene and NLRP3 inflammasome analysis. | |
| Healthy Controls | Age- and sex-matched healthy individuals without autoimmune or inflammatory disorders, recruited as controls. Blood samples will be analyzed similarly for comparison. |
What is being measured
The primary outcome is the main question the study is designed to answer.
TRPM2 gene polymorphism in vitiligo patients
Assessment of TRPM2 gene polymorphism by SNP genotyping in blood samples from vitiligo patients and healthy controls. The frequency and distribution of TRPM2 variants will be compared between groups.
Measured: At time of enrollment (single visit)
Secondary outcomes (3)
NLRP3 inflammasome expression in vitiligo patients
Quantification of NLRP3 inflammasome gene expression by real-time PCR (RT-qPCR) in peripheral blood of vitiligo patients and healthy controls. Expression levels will be compared between groups.
Measured: At time of enrollment (single visit)
Correlation between TRPM2 polymorphism and NLRP3 inflammasome expression
Correlation analysis between TRPM2 gene polymorphism and NLRP3 inflammasome expression among vitiligo patients to assess possible functional association.
Measured: At time of enrollment (single visit)
Association between TRPM2 gene polymorphism and disease severity
Comparison of TRPM2 gene polymorphism variants with vitiligo severity measured by Vitiligo Area Severity Index (VASI).
The Vitiligo Area Scoring Index (VASI) is a validated tool used to quantify vitiligo severity. Scores range from 0 to 100, where higher scores indicate greater disease severity. Assessment is performed at a single study visit.
Measured: At time of enrollment (single visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start20 Oct 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies 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
- 60 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Aswan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Ahmed Maher Sayed, Aswan University
- Investigators
- Mostafa Ahmed Maher, M.B.B.Ch., Principal investigator, Faculty of Medicine, Aswan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07232238
- Sponsor's protocol ID
- 897/1/24
- Status last verified
- Aug 2025
- First submitted
- 14 Nov 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Individual data sharing
- No: Individual participant data will not be shared. Summary results will be available in the final thesis and related publications.
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRPM2 Gene Polymorphism in Relation to NLRP3 Inflammasome Expression in Vitiligo Patients
- ClinicalTrials.gov ID
- NCT07232238
- Acronym / sponsor ID
- 897/1/24
- Conditions
- Vitiligo
- Keywords
- TRPM2, NLRP3, oxidative stress, inflammasome, genetic polymorphism
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Aswan UniversityUniversity, hospital or other
- Study start
- 20 Oct 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 18 Nov 2025 (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 investigates the relationship between Transient Receptor Potential Melastatin 2 (TRPM2) gene polymorphism and Nucleotide-binding oligomerization domain-like receptor protein 3 (NLRP3) inflammasome expression in patients with vitiligo. Vitiligo is a common autoimmune depigmenting disorder characterized by melanocyte destruction associated with oxidative stress and immune dysregulation.
TRPM2 is a calcium-permeable cation channel activated by oxidative stress, while NLRP3 inflammasome activation promotes inflammation through interleukin-1β (IL-1β) and interleukin-18 (IL-18) release. This study aims to evaluate TRPM2 genetic variants, NLRP3 expression levels, and their possible correlation with disease severity measured using the Vitiligo Area Scoring Index (VASI).
Detailed description
Vitiligo is a chronic autoimmune depigmenting disorder characterized by selective loss of melanocytes. Oxidative stress plays a central role in triggering melanocyte damage. Transient Receptor Potential Melastatin 2 (TRPM2) is a calcium-permeable cation channel activated by reactive oxygen species (ROS). Activation of TRPM2 leads to increased intracellular calcium (Ca2+) influx and mitochondrial dysfunction, contributing to melanocyte apoptosis.
The Nucleotide-binding oligomerization domain-like receptor protein 3 (NLRP3) inflammasome is an intracellular multiprotein complex activated by cellular stress signals, including Ca2+ influx, ROS, and mitochondrial injury. NLRP3 activation results in caspase-1 activation and the release of pro-inflammatory cytokines interleukin-1β (IL-1β) and interleukin-18 (IL-18), which further contribute to melanocyte destruction.
Evidence suggests an interaction between TRPM2 activation and NLRP3 inflammasome signaling, particularly under oxidative stress conditions. However, this relationship has not been studied in vitiligo patients. This study investigates TRPM2 gene polymorphism, evaluates NLRP3 expression levels, and explores their association with disease presence and severity.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitiligo Patients | – | –Participants clinically diagnosed with vitiligo, recruited from the Dermatology Outpatient Clinic, Aswan University Hospital. Peripheral blood samples will be collected for TRPM2 gene and NLRP3 inflammasome analysis. |
| Healthy Controls | – | –Age- and sex-matched healthy individuals without autoimmune or inflammatory disorders, recruited as controls. Blood samples will be analyzed similarly for comparison. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with clinically diagnosed vitiligo attending the Dermatology Department at Aswan University Hospital, Egypt, and healthy control participants matched for age and sex.
Key inclusion criteria (1 listed)
- Adult patients (aged 18 years and older) clinically diagnosed with vitiligo, either newly diagnosed or not on treatment for at least 3 months before the study.
Key exclusion criteria (5 listed)
- Any participant with associated inflammatory disease (such as infections or autoimmune disorders).
- Patients with chronic diseases including cardiac, hepatic, hematologic, or renal disorders, or malignancies.
- Patients who had recent major surgical procedures.
- Patients with segmental vitiligo.
- Vitiligo patients who have received treatment within 3 months prior to the study.
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
TRPM2 gene polymorphism in vitiligo patients
Time frame: At time of enrollment (single visit)
Assessment of TRPM2 gene polymorphism by SNP genotyping in blood samples from vitiligo patients and healthy controls. The frequency and distribution of TRPM2 variants will be compared between groups.
3 secondary outcomes
NLRP3 inflammasome expression in vitiligo patients
Time frame: At time of enrollment (single visit)
Correlation between TRPM2 polymorphism and NLRP3 inflammasome expression
Time frame: At time of enrollment (single visit)
Association between TRPM2 gene polymorphism and disease severity
Time frame: At time of enrollment (single visit)
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 31 Dec 2025.
- Faculty of Medicine, Aswan University official website.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. Summary results will be available in the final thesis and related publications.
Related trials for Vitiligo
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Two Trials to Evaluate TEV-53408 in Participants With Non-Segmental Vitiligo
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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.
Mostafa Ahmed Maher, M.B.B.Ch. principal investigator
Faculty of Medicine, Aswan University
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 Vitiligo, run by Aswan 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 1 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: under way, not looking for participants, as of the sponsor's last update on 31 Dec 2025. 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?
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?
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?
TRPM2 gene polymorphism in vitiligo patients (time frame: At time of enrollment (single visit)). 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 31 Dec 2025.