Serum IL-21 Levels in Patients With Pemphigus Vulgaris
1 other identifier
observational
20
0 countries
N/A
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2017
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2017
CompletedFirst Submitted
Initial submission to the registry
June 2, 2017
CompletedFirst Posted
Study publicly available on registry
June 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedJune 6, 2017
June 1, 2017
1.3 years
June 2, 2017
June 4, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
serum IL-21
serum IL-21 level
2 months
Study Arms (2)
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.
Eligibility Criteria
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.
You may qualify if:
- pemphigus vulgaris patients
- healthy age and sex matched
You may not qualify if:
- \- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (11)
Zhu H, Chen Y, Zhou Y, Wang Y, Zheng J, Pan M. Cognate Th2-B cell interaction is essential for the autoantibody production in pemphigus vulgaris. J Clin Immunol. 2012 Feb;32(1):114-23. doi: 10.1007/s10875-011-9597-4. Epub 2011 Oct 19.
PMID: 22009001BACKGROUNDAmber KT, Staropoli P, Shiman MI, Elgart GW, Hertl M. Autoreactive T cells in the immune pathogenesis of pemphigus vulgaris. Exp Dermatol. 2013 Nov;22(11):699-704. doi: 10.1111/exd.12229.
PMID: 24433179RESULTAmagai M, Klaus-Kovtun V, Stanley JR. Autoantibodies against a novel epithelial cadherin in pemphigus vulgaris, a disease of cell adhesion. Cell. 1991 Nov 29;67(5):869-77. doi: 10.1016/0092-8674(91)90360-b.
PMID: 1720352RESULTCholera M, Chainani-Wu N. Management of Pemphigus Vulgaris. Adv Ther. 2016 Jun;33(6):910-58. doi: 10.1007/s12325-016-0343-4. Epub 2016 Jun 10.
PMID: 27287854RESULTDi Zenzo G, Amber KT, Sayar BS, Muller EJ, Borradori L. Immune response in pemphigus and beyond: progresses and emerging concepts. Semin Immunopathol. 2016 Jan;38(1):57-74. doi: 10.1007/s00281-015-0541-1. Epub 2015 Nov 23.
PMID: 26597100RESULTGomez-Martin D, Diaz-Zamudio M, Romo-Tena J, Ibarra-Sanchez MJ, Alcocer-Varela J. Follicular helper T cells poise immune responses to the development of autoimmune pathology. Autoimmun Rev. 2011 Apr;10(6):325-30. doi: 10.1016/j.autrev.2010.11.007. Epub 2010 Dec 15.
PMID: 21167320RESULTHertl M, Amagai M, Sundaram H, Stanley J, Ishii K, Katz SI. Recognition of desmoglein 3 by autoreactive T cells in pemphigus vulgaris patients and normals. J Invest Dermatol. 1998 Jan;110(1):62-6. doi: 10.1046/j.1523-1747.1998.00086.x.
PMID: 9424089RESULTKneisel A, Hertl M. Autoimmune bullous skin diseases. Part 1: Clinical manifestations. J Dtsch Dermatol Ges. 2011 Oct;9(10):844-56; quiz 857. doi: 10.1111/j.1610-0387.2011.07793.x. English, German.
PMID: 21955378RESULTKneisel A, Hertl M. Autoimmune bullous skin diseases. Part 2: diagnosis and therapy. J Dtsch Dermatol Ges. 2011 Nov;9(11):927-47. doi: 10.1111/j.1610-0387.2011.07809.x. English, German.
PMID: 22026362RESULTRosenbach M, Murrell DF, Bystryn JC, Dulay S, Dick S, Fakharzadeh S, Hall R, Korman NJ, Lin J, Okawa J, Pandya AG, Payne AS, Rose M, Rubenstein D, Woodley D, Vittorio C, Werth BB, Williams EA, Taylor L, Troxel AB, Werth VP. Reliability and convergent validity of two outcome instruments for pemphigus. J Invest Dermatol. 2009 Oct;129(10):2404-10. doi: 10.1038/jid.2009.72. Epub 2009 Apr 9.
PMID: 19357707RESULTVogelzang A, McGuire HM, Yu D, Sprent J, Mackay CR, King C. A fundamental role for interleukin-21 in the generation of T follicular helper cells. Immunity. 2008 Jul 18;29(1):127-37. doi: 10.1016/j.immuni.2008.06.001. Epub 2008 Jul 3.
PMID: 18602282RESULT
Biospecimen
Blood sample
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- AssiutU
Study Record Dates
First Submitted
June 2, 2017
First Posted
June 6, 2017
Study Start
June 1, 2017
Primary Completion
September 1, 2018
Study Completion
December 1, 2018
Last Updated
June 6, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share