Comparative Analysis of the Th17 Cellular Response in Active and Inactive Pemphigus Vulgaris Patients

• Conditions: Pemphigus Vulgaris; Bullous Dermatoses; Autoimmune Diseases

• Registration Number: NCT04096222
• Lead Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Brief Summary

This study will compare the pattern of Th17 immune response in active and inactive pemphigus subjects. Skin and serum samples will be taken at the moment of enrollment.

Detailed Description

Pemphigus is an autoimmune disease characterized by production of autoantibodies against desmogleins 1 and 3, which are part of the epidermis desmosomes. The first line of treatment are corticosteroids with or without the use of adjuvants (e.g. azathioprine, mycophenolate or rituximab). T lymphocytes are responsible for the initiation and maturation of the humoral response and the B cell activation required for the production of autoantibodies. In the last decade, the Th17 immune response has been implicated in the pathogenesis of pemphigus. Recently, the existence of tertiary lymphoid organ-like structures within the skin lesions was suggested. This structures contain T lymphocytes, B lymphocytes and plasma cells; these cells interact and create a local microenvironment for the production of autoantibodies. Most of the T cells in this structures are T helper CD4+ and express IL-21, and half of them produce IL-17.

In this study the investigators aim to evaluate comparatively the Th17 and T regulatory immune response in the lesional skin and serum of active and inactive pemphigus subjects that are treated with corticosteroids with or without adjuvants and a third group of healthy subjects. The investigators will study skin and serum due to the difference of lymphocytes and cytokines in both tissues. The primary hypothesis is: active pemphigus vulgaris subjects will have different levels of TH17 response in comparison to inactive patients.

The investigators will use descriptive statistics, association and correlation test of hypothesis.

Study Timeline

• Study First Submitted: 2019-08-15
• Study First Submitted QC: 2019-09-18
• Study First Posted: 2019-09-19
• Study Start: 2021-06-29
• Status Verified: 2022-03
• Last Update Submitted: 2022-08-08
• Last Update Posted: 2022-08-10
• Primary Completion: 2023-03-28
• Study Completion: 2023-03-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

1. Current cutaneous activity of pemphigus
2. Subjects will be treated with corticosteroids with or without adjuvants
3. Accept and sign the informed consent

Exclusion Criteria

1. Pregnancy
2. Concurrent autoimmune diseases with skin lesions
3. Concurrent diagnosis of cancer
4. Concurrent active infectious disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Level of Th17 cytokines in skin of pemphigus vulgaris subjects	Enrollment	The level of IL-17a, IL-21, IL-22, and IL-23 mRNA from skin biopsies at the time of enrollment and when the subject reaches 75% of PDAI improvement or after a year of follow-up (termination visit). The percentage of change in these two determinations will be calculated.

Trial Locations

Locations (2)

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran; 🇲🇽 Mexico City, Mexico

Hospital General Dr. Manuel Gea González; 🇲🇽 Mexico City, Mexico