Pemphigus Clinical Trial
Official title:
Activation of Coagulation as an Indicator of a Pro-thrombotic State in Patients With Pemphigus: A Case-control Study
Aim of work: 1. To evaluate the plasma markers of coagulation activation: prothrombin F1+2 and d-dimer levels in pemphigus patients with active disease and compare them with age and sex-matched controls. 2. To evaluate the correlation of these markers with disease severity score by using Pemphigus Disease Area Index (PDAI) and with disease activity by measurement of anti-desmoglein 1 and 3 antibody titers.
Status | Not yet recruiting |
Enrollment | 54 |
Est. completion date | February 2026 |
Est. primary completion date | October 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - pemphigus vulgaris patients at active stage of the disease. - patients between the ages of 18 and 60. Exclusion Criteria: - Patients with other autoimmune bullous diseases. - Patients with other skin diseases. - Patients with chronic liver, renal or haematological diseases. - Patients with malignant tumors. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Assiut University |
Beek NV, Zillikens D, Schmidt E. Bullous Autoimmune Dermatoses-Clinical Features, Diagnostic Evaluation, and Treatment Options. Dtsch Arztebl Int. 2021 Jun 18;118(24):413-420. doi: 10.3238/arztebl.m2021.0136. — View Citation
Capecchi M, Scalambrino E, Griffini S, Grovetti E, Clerici M, Merati G, Chantarangkul V, Cugno M, Peyvandi F, Tripodi A. Relationship between thrombin generation parameters and prothrombin fragment 1 + 2 plasma levels. Int J Lab Hematol. 2021 Oct;43(5):e2 — View Citation
Egami S, Yamagami J, Amagai M. Autoimmune bullous skin diseases, pemphigus and pemphigoid. J Allergy Clin Immunol. 2020 Apr;145(4):1031-1047. doi: 10.1016/j.jaci.2020.02.013. — View Citation
Gregoriou S, Efthymiou O, Stefanaki C, Rigopoulos D. Management of pemphigus vulgaris: challenges and solutions. Clin Cosmet Investig Dermatol. 2015 Oct 21;8:521-7. doi: 10.2147/CCID.S75908. eCollection 2015. — View Citation
Jiang C, Adjei S, Santiago S, Lu J, Duran M, Tyring S. Novel use of dupilumab in pemphigus vulgaris and pemphigus foliaceus. JAAD Case Rep. 2023 Sep 30;42:12-15. doi: 10.1016/j.jdcr.2023.09.018. eCollection 2023 Dec. No abstract available. — View Citation
Kridin K, Kridin M, Amber KT, Shalom G, Comaneshter D, Batat E, Cohen AD. The Risk of Pulmonary Embolism in Patients With Pemphigus: A Population-Based Large-Scale Longitudinal Study. Front Immunol. 2019 Jul 24;10:1559. doi: 10.3389/fimmu.2019.01559. eCol — View Citation
Lee SH, Hong WJ, Kim SC. Analysis of Serum Cytokine Profile in Pemphigus. Ann Dermatol. 2017 Aug;29(4):438-445. doi: 10.5021/ad.2017.29.4.438. Epub 2017 Jun 21. — View Citation
Leshem YA, Atzmony L, Dudkiewicz I, Hodak E, Mimouni D. Venous thromboembolism in patients with pemphigus: A cohort study. J Am Acad Dermatol. 2017 Aug;77(2):256-260. doi: 10.1016/j.jaad.2017.01.059. Epub 2017 May 9. — View Citation
Marin M, Orso D, Federici N, Vetrugno L, Bove T. D-dimer specificity and clinical context: an old unlearned story. Crit Care. 2021 Mar 10;25(1):101. doi: 10.1186/s13054-021-03532-6. No abstract available. — View Citation
Rosenbach 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 vali — View Citation
Shaheen MS, Silverberg JI. Association of inflammatory skin diseases with venous thromboembolism in US adults. Arch Dermatol Res. 2021 May;313(4):281-289. doi: 10.1007/s00403-020-02099-6. Epub 2020 Jul 8. — View Citation
Yang P, Li H, Zhang J, Xu X. Research progress on biomarkers of pulmonary embolism. Clin Respir J. 2021 Oct;15(10):1046-1055. doi: 10.1111/crj.13414. Epub 2021 Aug 3. — View Citation
Yuan Q, Yang W, Zhang X. Immune cells in pemphigus vulgaris and bullous Pemphigoid: From pathogenic roles to targeting therapies. Int Immunopharmacol. 2023 Oct;123:110694. doi: 10.1016/j.intimp.2023.110694. Epub 2023 Jul 29. — View Citation
* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of coagulation activation markers in pemphigus patients with controls | Evaluate the plasma markers of coagulation activation: prothrombin F1+2 and d-dimer levels in pemphigus patients with active disease and compare them with age and sex-matched controls. | Baseline | |
Secondary | Correlation of markers with disease severity | Evaluate correlation of these markers with disease severity score by using Pemphigus Disease Area Index (PDAI) and with disease activity by measurement of anti-desmoglein 1 and 3 antibody titers. | Baseline |
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