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

NCT04096222 | Unknown

• 1 other identifier: 3012
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 2

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.

Conditions

Pemphigus Vulgaris; Bullous Dermatoses; Autoimmune Diseases

Keywords

pemphigus; Th17; IL-23; IL-17; autoimmune bullous disease

Outcome Measures

Primary Outcomes (1)

• 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.

  Enrollment

Other Outcomes (14)

• Pemphigus Disease Area Index (PDAI)

  Enrollment

• Disease activity

  Enrollment

• Autoimmune Bullous Skin Disorder Intensity Score (ABSIS)

  Enrollment

Study Arms (3)

Active pemphigus vulgaris subjects

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

Inactive pemphigus vulgaris subjects

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

• Pregnancy
• Concurrent autoimmune diseases with skin lesions
• Concurrent diagnosis of cancer
• Concurrent active infectious disease

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead
• Hospital General Dr. Manuel Gea González: collaborator

Study Sites (2)

Hospital General Dr. Manuel Gea González

Mexico City, 14080, Mexico

NOT YET RECRUITING

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, 14080, Mexico

RECRUITING

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• Zhao M, Huang W, Zhang Q, Gao F, Wang L, Zhang G, Su Y, Xiao R, Zhang J, Tang M, Cheng W, Tan Y, Lu Q. Aberrant epigenetic modifications in peripheral blood mononuclear cells from patients with pemphigus vulgaris. Br J Dermatol. 2012 Sep;167(3):523-31. doi: 10.1111/j.1365-2133.2012.11007.x. Epub 2012 Aug 10.

  PMID: 22512277 BACKGROUND

MeSH Terms

Conditions

Pemphigus; Skin Diseases, Vesiculobullous; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Immune System Diseases

Study Officials

• Luis Guillermo Llorente Peters, MD

  Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luis Guillermo Llorente Peters, MD

CONTACT

525554870900; luisllorentepeters57@gmail.com

Alba Cicero Casarrubias, MD

CONTACT

525554870900; albcicero@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2019
• First Posted: September 19, 2019
• Study Start: June 29, 2021
• Primary Completion: March 28, 2023
• Study Completion: March 28, 2023
• Last Updated: August 10, 2022

Record last verified: 2022-03

Locations

ME (2)