Evaluation of Pyroptosis-related Indicators in the Pathogenesis of Vitiligo:Across-sectional Comparative Study

February 8, 2024 updated by: Marwa Abdelmawla Mohamed, Sohag University

Vitiligo is an acquired pigmentary disorder on skin and/or mucosae, which is characterized by death of melanocytes (MCs), affecting 0.5%-2% of the population worldwide (1). It doesn't affect the health of patients but it has marked social pressure and greatly interfere with their quality of life (2,3). It presents with well circumscribed milky white patches that occur secondary to destruction of melanocyte, it may appear at any age and affect both sexes equally.

It can affect ethnic groups and people of all skin types with no predilection (4).

Clinically, several types of vitiligo are distinguished according to the distribution of the achromic lesions. One or more lesions in a dermatomal pattern are characteristic for segmental vitiligo (SV) while this segmental distribution is absent in non-segmental vitiligo (NSV). The latter variety includes both the focal type and the generalized type (5). Numerous previous studies tried to illustrate the pathogenesis behind the disease, but the exact pathophysiology is still not fully understood. It is a multifactorial disease. Factors include, neural theory, oxidative stress theory, autoimmune hypothesis, intrinsic theory, melanocytorrhagy hypothesis (6). Many theories tried to explain the mechanisms of MC destruction in vitiligo. Apoptosis is one of the most widely studied cell death pathways. In addition, the other two forms of cell death, conventional necrosis and autophagy seem to be involved in the death of vitiligo MCs under certain situations. Moreover, new types of regulated cell death including necroptosis, pyroptosis, and ferroptosis may also participate in the pathogenesis (7). Pyroptosis is a highly inflammatory form of necrosis cell death NCD regulated mainly by caspase-1, which is initiated following large supramolecular complex ermed inflammasome activation (8). The inflammasome-activated Caspases then cleave the pyroptosis-inducing protein Gasdermin D (GSDMD), which forms a pore in the plasma membrane and causes cell lysis as well as the secretion of IL-1β typically (9). Another study suggests that inflammasome activation could be a useful marker for assessing disease progression of vitiligo (10). However, the link between vitiligo and inflammasome activation is still unclear. The inflammasome regulates cell death and inflammation via activation of caspase-1 (11). The activation of caspase-1 promotes the secretion of proinflammatory cytokines IL-1β and IL-18, as well as the initiation of pyroptosis (12). So, evaluation of pyroptosis-related indicators (GASDM-D, IL 1β & IL-18) may help understanding the obscure inflammasome pathway involvement in the pathogenesis of Vitiligo.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

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

Study Contact Backup

  • Name: essam eldin A nada, professor

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

Description

Inclusion Criteria:

  • Patients with vitiligo ≥ 18 years old, both male and female patients will be included.

Exclusion Criteria:

  • Patients with the following criteria will be excluded from our study:

    1. Pregnancy and breast-feeding women
    2. patients on antioxidants or anti-inflammatory drugs
    3. Patients on topical/systemic treatment for vitiligo in the last 4weeks prior to enrollment in the study
    4. Patients with other dermatological diseases as psoriasis, lichen planus, viral infection, etc.
    5. Patients suffering from chronic medical illness such as; diabetes mellitus, thyroid disease, and cancer.

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: patient with vitiligo group

Patients with vitiligo ≥ 18 years old, both male and female patients will be included.

Exclusion criteria:

Patients with the following criteria will be excluded from our study:

  1. Pregnancy and breast-feeding women.
  2. patients on antioxidants or anti-inflammatory drugs
  3. Patients on topical/systemic treatment for vitiligo in the last 4weeks prior to enrollment in the study
  4. Patients with other dermatological diseases as psoriasis, lichen planus, viral infection, etc.
  5. Patients suffering from chronic medical illness such as; diabetes mellitus, thyroid disease, and cancer.
Diagnostic test: evaluate serum levels pyroptosis-related indicators (GASDM-D, IL 1β & IL-18)
2 ml blood will be collected from all participants (patients and controls) by aseptic venipuncture into plain tubes. Then the samples will be allowed to coagulate during 10-20 minutes. Serum will be obtained by centrifugation at speed of 2000-3000 cycle/min for 20 minutes. Then we collect the supernatant which immediately be frozen at -80°C until analyzed to determine serum levels of pyroptosis-related indicators (GASDM-D, IL 1β & IL-18). Serum concentration will be assessed by a commercially available double antibody sandwich enzyme-linked immunosorbent assay (ELISA) kit
Active Comparator: control group

control criteria with the following criteria will be excluded from our study:

1- Pregnancy and breast-feeding women.
Diagnostic test: evaluate serum levels pyroptosis-related indicators (GASDM-D, IL 1β & IL-18)
2 ml blood will be collected from all participants (patients and controls) by aseptic venipuncture into plain tubes. Then the samples will be allowed to coagulate during 10-20 minutes. Serum will be obtained by centrifugation at speed of 2000-3000 cycle/min for 20 minutes. Then we collect the supernatant which immediately be frozen at -80°C until analyzed to determine serum levels of pyroptosis-related indicators (GASDM-D, IL 1β & IL-18). Serum concentration will be assessed by a commercially available double antibody sandwich enzyme-linked immunosorbent assay (ELISA) kit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GASDM-D
Time Frame: 6 months
Evaluartion of serum level of (GASDM-D) in patients with Vitiligo as well as in control health group. 2- To correlate level of GASDM-D with severity of the disease.
6 months
IL 1β
Time Frame: 6 months
Evaluation of serum level of IL 1β in patients with Vitiligo as well as in control health group 2- To correlate level of IL 1β with severity of the disease.
6 months
IL-18
Time Frame: 6 months
Evaluation of serum level of IL-18 in patients with Vitiligo as well as in control health group 2- To correlate level of IL-18 with severity of the disease.
6 months

Collaborators and Investigators

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

Sponsor

Sohag 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)

February 24, 2024

Primary Completion (Estimated)

August 24, 2024

Study Completion (Estimated)

August 24, 2024

Study Registration Dates

First Submitted

February 8, 2024

First Submitted That Met QC Criteria

February 8, 2024

First Posted (Estimated)

February 15, 2024

Study Record Updates

Last Update Posted (Estimated)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • soh-med-24-01-06MS

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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