Serum IL-21 Levels in Patients With Pemphigus Vulgaris

June 4, 2017 updated by: Marwa Kassim, Assiut University
Pemphigus is severe antigen derived autoimmune bullous skin disorder, the word pemphigus is derived from the Greek word" pemphix " which means blister . Two main clinical variants are known pemphigus vulgaris (PV), and pemphigu foliaceus (PF). (Zenzo .et al., 2015).

Study Overview

Status

Unknown

Conditions

Detailed Description

Clinically, there are localized or generalized flaccid bullae that quickly transform into post-bullous erosions and crusts , PV patients characteristically develop oral lesions with buccal and/or gingival persisting erosions (mucosal dominant PV) which several weeks or months later may also spread to the epidermis (mucocutaneous PV). PF is characterized by widespread cutaneous fragile bullae which rapidly rupture, resulting in erosions, crusting, and scaling. In contrast to PV, the mucosa is usually not involved in PV. (Zenzo .et al .,2015).

Pathophysiologically, the underlying intraepithelial blister formation is caused by IgG autoantibodies against the desmosomal adhesion proteins, desmoglein 3 and/or desmoglein 1, on epidermal keratinocytes. ( Amagai .et al .,1991) In PV the antigen is desmoglein 3 which is presented in lower epidermis and is expressed more strongly in buccal mucosa than in the skin ,in contrast to PF which its antigen is desmoglein 1 which is expressed in the skin throughout the epidermis and weakly expressed in the mucous membranes . ( Kneisel and Hertl. .,2011).

T cells play a crucial role in the pathogenesis of pemphigus vulgaris , The interaction of T and B cells critically modulates the development of pemphigus vulgaris. (Amber. et al., 2013 ; Zhu, et al.,2012).

Because B-cell activation and antibody production classically necessitate the involvement of CD4+ T cells, Dsg-reactive T cells were capable of recognizing multiple epitopes of the extracellular domain of Dsg and helping B cells to produce a specific antibody. Dsg3-reactive T-cell clones were able to commit polyclonal naive B cells to produce pathogenic anti-Dsg3 antibody and induce the PV phenotype. (Hertl . et al., 1998) Follicular T helper cells (Tfh) are a recently discovered group of CD4+ Th cells with intrinsic differences from Th1, Th2 and Th17 cells. Localized in B-cell follicles of secondary lymphoid tissues, The major function of Tfh cells appears to help B-cell activation and antibody production during humoral immune responses. The Tfh cells express high levels of IL-21, which was demonstrated to be important for the generation of Tfh cells and that responsiveness of Tfh cells to IL-21 drives the formation of the autoimmune reaction, and it clearly impacted on the amount of antibody production.( Gomez. et al.,2011 ; Vogelzang . et al.,2008) Nowadays, finding a promising treatment for pemphigus remains a serious challenge. Various treatments are currently recommended to treat this disease, but they rarely lead to complete and durable remission. Regulatory cells appear to have a critical role in numerous autoimmune diseases, so it is possible that control of these cells may induce remission. (Cholera and Chainani .,2016)

Study Type

Observational

Enrollment (Anticipated)

20

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

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

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

20 pemphigus vulgaris patients will be included in the study, either newly diagnosed or recurrent. Patients will be recruited on admission from Dermatology department and Outpatient Clinic, Assiut University Hospitals. 10 healthy age and sex matched subjects will be included as controls.

Description

Inclusion Criteria:

  • 20 pemphigus vulgaris patients
  • healthy age and sex matched

Exclusion Criteria:

  • - Patients with a history of topical or systemic treatment (corticosteroids, intralesional steroid injection, immunosuppressive therapy, anticonvulsants and anticancer medications, within 4 weeks of the study.
  • Patients receiving phototherapy within 6 months of the study .
  • Patients with a history of diabetes mellitus, anemia, thyroid or parathyroid disorders, chronic liver or renal diseases, or atopy .
  • Patients with known autoimmune diseases or cancer.
  • Pregnant or lactating women were also excluded from 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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
pemphigus vulgaris patients
20 pemphigus vulgaris patients will be included in the study, either newly diagnosed or recurrent. Patients will be recruited on admission from Dermatology department and Outpatient Clinic, Assiut University Hospitals
Healthy controls
10 healthy age and sex matched subjects will be included as controls.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum IL-21
Time Frame: 2 months
serum IL-21 level
2 months

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 (Anticipated)

June 1, 2017

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

June 2, 2017

First Submitted That Met QC Criteria

June 4, 2017

First Posted (Actual)

June 6, 2017

Study Record Updates

Last Update Posted (Actual)

June 6, 2017

Last Update Submitted That Met QC Criteria

June 4, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IL-21PV

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

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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