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

  • End date
    Mar 28, 2023
  • participants needed
  • sponsor
    Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Updated on 3 September 2021


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.


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.

Condition Bullous Dermatoses, autoimmune diseases, Pemphigus, Dermatosis, autoimmune disorder, Autoimmune Disease, Skin Conditions, Autoimmunity, Autoimmune disease, Pemphigus Vulgaris (PV), Congenital Skin Diseases, autoimmune disorders
Clinical Study IdentifierNCT04096222
SponsorInstituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Last Modified on3 September 2021


Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Concurrent autoimmune diseases with skin lesions
Concurrent diagnosis of cancer
Concurrent active infectious disease
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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