Evaluation of Serum Gasdermin D Level As a Potential Biomarker of Disease Activity in Vitiligo Patients

September 3, 2024 updated by: Fatma Ashraf Sayed Abdelghany, Assiut University
Assessment the serum level of Gasdermin D level in vitiligo patients. Correlate its level with disease activity scores using Vitiligo Area Severity Index (VASI) and Vitiligo Disease Activity (VIDA) scores and with different disease parameters.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Vitiligo, a common depigmenting skin disorder, has an estimated prevalence of 0.5-2% of the population worldwide. The disease is characterized by the selective loss of melanocytes which results in typical nonscaly, chalky-white macules. In recent years, considerable progress has been made in our understanding of the pathogenesis of vitiligo which is now clearly classified as an autoimmune disease .

The destruction of melanocyte is thought to be of multifactorial causation. Genome-wide associated studies have identified single-nucleotide polymorphisms in a panel of susceptible loci as risk factors in melanocyte death. But vitiligo onset can't be solely attributed to a susceptive genetic background .

Oxidative stress triggered by elevated levels of reactive oxygen species accounts for melanocytic molecular and organelle dysfunction, in addition to the self-responsive immune function directly contributes to the bulk of melanocyte deaths in vitiligo .

Moreover, apoptosis is the most extensively documented way of melanocyte demise, with few melanocytes undergo necrosis. But forms of cell death are not merely restricted to apoptosis and necrosis. Cells may die from accidental cell death (ACD) or regulated cell death (RCD). ACD, like necrosis, is biologically uncontrolled, whereas RCD (apoptosis, necroptosis, pyroptosis, oxeiptosis, ferroptosis, parthanatos, etc.) involves precise signaling cascade and molecular mechanisms .

Pyroptosis is mechanistically distinct from other forms of cell death with gasdermin D (GSDMD) and caspase-1/4/5/11 activation as its defining feature . Upon being stimulated by damage-associated molecular patterns molecules (DAMPs), pathogen-associated molecular patterns molecules or altered homeostasis, caspases are activated to cleave the downstream GSDMD. GSDMD fragment with membrane pore-forming activity yields plasma membrane rupture, cytosolic content release, and concurrent cell swelling and lysis

Gasdermins belong to the pore-forming protein family and consist of six gasdermin proteins, including gasdermins A-E. The members of the gasdermin family have two domains: an N-terminal domain and a C-terminal domain linked by a flexible peptide. Upon activation, the cleaved N-terminal domain is responsible for inducing pyroptosis . GSDMD, the most extensively studied executive pyroptosis-executing protein with the clearest mechanism.

In a previous study, scRNA-seq datasets of skin-derived cells from healthy donors and patients with vitiligo were analysed. Results demonstrated that CASP1, CASP4, CASP6, CASP8, and GSDMD expression was significantly upregulated in melanocytes of patients with vitiligo. These results indicated that pyroptosis signaling is an important pathway in the development of vitiligo .

To the best of our knowledge, no previous studies have evaluated the serum level of Gasdermin D as a potential biomarker in vitiligo patients.

Study Type

Observational

Enrollment (Estimated)

84

Contacts and Locations

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

Study Contact

  • Name: Fatma Ashraf Sayed abdelgany, resisdant doctor
  • Phone Number: 0882210622
  • Email: fy23237@gmail.com

Study Contact Backup

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

For every patient, a full history will be taken recording age, gender, education, residence, special habits, age at onset of vitiligo, duration of vitiligo, stability of vitiligo and family history. A detailed cutaneous examination will be performed including skin phototype, Koebner phenomenon, vitiligo clinical type, leukotrichia, Vitiligo Area Severity Index (VASI) and Vitiligo Disease Activity (VIDA) scores.

Description

Inclusion Criteria:

  • All clinically diagnosed cases of vitiligo (segmental and non-segmental).

Exclusion Criteria:

  1. patients with inflammatory diseases.
  2. patients with autoimmne diseases.
  3. patients with neurodegenerative diseases.
  4. patients with HIV or COVID19 infection or any other type of infections.
  5. patients with systemic diseases as liver diseases or having tumors.
  6. patients who received systemic treatment in the last 3 months or topical treatment 1 month prior to the study.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment the serum level of Gasdermin D level in vitiligo patients
Time Frame: basline
estimate the serum level of Gasdermin D level in vitiligo patients and correlate its level with disease activity and various disease parameters.
basline

Collaborators and Investigators

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

Sponsor

Assiut 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 (Estimated)

November 1, 2024

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

December 18, 2023

First Submitted That Met QC Criteria

September 3, 2024

First Posted (Estimated)

September 5, 2024

Study Record Updates

Last Update Posted (Estimated)

September 5, 2024

Last Update Submitted That Met QC Criteria

September 3, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Serum Gasdermin D in vitiligo

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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