TRPM2 Gene Polymorphism, NLRP3 Inflammasome Expression in Vitiligo Patients

NCT07232238 | Active Not Recruiting

• 1 other identifier: 897/1/24
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Vitiligo

Keywords

TRPM2, NLRP3, oxidative stress, inflammasome, genetic polymorphism

Outcome Measures

Primary Outcomes (1)

• 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.

  At time of enrollment (single visit)

Secondary Outcomes (3)

• NLRP3 inflammasome expression in vitiligo patients

  At time of enrollment (single visit)

• Correlation between TRPM2 polymorphism and NLRP3 inflammasome expression

  At time of enrollment (single visit)

• Association between TRPM2 gene polymorphism and disease severity

  At time of enrollment (single visit)

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aswan University: lead

Study Sites (1)

Aswan University Hospital

Aswān, Aswan Governorate, 81528, Egypt

Location

Related Links

• Faculty of Medicine, Aswan University official website.

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood samples collected from vitiligo patients and healthy controls for DNA extraction and molecular analysis. Remaining material will be discarded after completion of testing.

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mostafa Ahmed Maher, M.B.B.Ch.

  Faculty of Medicine, Aswan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator / MD Candidate

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: October 20, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: December 31, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)