An observational study in Pemphigus Vulgaris, Bullous Dermatoses and Autoimmune Diseases, sponsored by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran. Status unknown at 2 sites in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-10.
Sponsored by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran · Observational
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.
76 studies on the registry are indexed under Pemphigus; 18 are open to participants now.
This study's planned enrollment of 42 is below the median of 60 across 21 observational studies indexed under Pemphigus.
Browse Pemphigus studies →Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran is the lead sponsor of 144 studies on the registry; 16 are open to participants now.
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Subjects with the diagnosis of pemphigus who are 18 or older and who have curent skin activity and will receive treatment with corticosteroids with or without adjuvants. At the moment of enrollment subjects shoould not be pregnant, have concurrent autoimmune diseases with skin lesions (eg cutaneous lupus), cancer or infectious diseases.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects with the diagnosis of pemphigus and with active or inactive disease in the skin will be invited to participate. After informed consent, at the enrollment visit the following interventions will be done: 1) two 4 mm punch biopsies in a target lesion, 2) A 34 ml blood sample will be taken, 3) photographs of the subject, 4) demographic, disease, comorbidity and treatment data will be documented, 5) PDAI and ABSIS, 6) Biometric data
Subjects with the diagnosis of pemphigus and with active or inactive disease in the skin will be invited to participate. After informed consent, at the enrollment visit the following interventions will be done: 1) two 4 mm punch biopsies in a target lesion, 2) A 34 ml blood sample will be taken, 3) photographs of the subject, 4) demographic, disease, comorbidity and treatment data will be documented, 5) PDAI and ABSIS, 6) Biometric data
Healthy subjects will be invited to participate. After informed consent, at the enrollment visit the following interventions will be done: 1) Demographic data will be documented, 2) biometric data, 3) A 34 ml blood sample will be taken
Level of Th17 cytokines in skin of pemphigus vulgaris subjects
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.
Time frame: Enrollment
Pemphigus Disease Area Index (PDAI)
PDAI has a total of 0-263 points, 250 are related to activity and 13 to damage. Disease severity is considered as follows: 1) moderate \<= 14 points; b) significative 15-44 points; and c) extensive \>=45
Time frame: Enrollment
Disease activity
Measured with Pemphigus Disease Area Index (PDAI) and Autoimmune Bullous Skin Disorder Intensity Score (ABSIS). PDAI has a total of 0-263 points, 250 are related to activity and 13 to damage. ABSIS has a total score of 0-206.
Time frame: Enrollment
Autoimmune Bullous Skin Disorder Intensity Score (ABSIS)
ABSIS has a total score of 0-206. Disease severity is considered as follows: 1) moderate \<= 16 points; b) significative 17-52 points; and c) extensive \>=53
Time frame: Enrollment
Treatment
The medications and doses used since the diagnosis and during the study
Time frame: Enrollment
Proportion of Th17 and Treg populations on skin biopsies
iopsies will be processed for immunohistochemistry for TH17 subsets (CD+IL17a+) and Treg subset (CD25+Foxp3+). The proportion of both subsets will be quantified with specialized software.
Time frame: Enrollment
Level of Th17 cytokines in serum of pemphigus vulgaris subjects
The level of IL-17a, IL-21, IL-22 and IL-23 determined by luminometry
Time frame: Enrollment
Level of Th17 chemokines levels
The level of CCL20 and CXCL8 mRNA from skin biopsies and in serum by luminometry
Time frame: Enrollment
Level of Treg cytokines
Determination in skin (RT-PCR) and serum (luminometry) of CCL20 and CXCL8
Time frame: Enrollment
Level of Treg chemokines
Determinations at the moment of enrollment and at the termination visit in skin (RT-PCR) and serum (luminometry)
Time frame: Enrollment
P-glycoprotein transporter activity in mononuclear peripheral cells
The activity will be a measure of the percentage of efflux of daunorubicin ar 37°C.
Time frame: Enrollment
Percentage of Th17 peripheral cells with expression of P-glycoprotein on the surface
Cells with the phenotype IL-17a+CCR6+CXR3hiCCR4loCCR10-CD161+PGP+ will be measured with flow cytometry
Time frame: Enrollment
Levels of anti-desmogleins 1 and 3
Levels will be measures with an ELISA assay
Time frame: Enrollment
Proportion of peripheral cellular subpopulations
Determinations with flow cytometry
Time frame: Enrollment
Level of cytokines in supernatant of cellular culture
Determinations at the moment of enrollment with ELISA
Time frame: Enrollment
This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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