NCT06285435

Brief Summary

Aim of work:

  1. 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 29, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

February 29, 2024

Status Verified

February 1, 2024

Enrollment Period

1.6 years

First QC Date

February 22, 2024

Last Update Submit

February 22, 2024

Conditions

Pemphigus

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Correlation of markers with disease severity

    Baseline

Study Arms (2)

pemphigus vulgaris patients

Diagnostic Test: prothrombin fragment 1+2

control group

Diagnostic Test: prothrombin fragment 1+2

Interventions

prothrombin fragment 1+2DIAGNOSTIC_TEST

Blood sample

Also known as: D-dimer
control grouppemphigus vulgaris patients

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with active pemphigus who are either in a relapse for less than a week or are newly diagnosed cases will be included. The active stage of PV is defined as the de novo development of blisters on a healthy (unaffected or healed) site of either the skin or the mucous membrane. Clinical assessment, histopathological analysis (acantholysis and intraepidermal splitting) will be used to confirm the diagnosis of each patient. Control group: Healthy age and sex-matched subjects, who are free of chronic systemic diseases or dermatological conditions, will be enrolled as control.

You may qualify if:

  • pemphigus vulgaris patients at active stage of the disease.
  • patients between the ages of 18 and 60.

You may not qualify if:

  • Patients with other autoimmune bullous diseases.
  • Patients with other skin diseases.
  • Patients with chronic liver, renal or haematological diseases.
  • Patients with malignant tumors.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • 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.

    PMID: 26543381RESULT

  • 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.

    PMID: 37965194RESULT

  • 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.

    PMID: 34369370RESULT

  • 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.

    PMID: 37523970RESULT

  • 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. eCollection 2019.

    PMID: 31396203RESULT

  • 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.

    PMID: 32642810RESULT

  • 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.

    PMID: 34214256RESULT

  • 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.

    PMID: 33691711RESULT

  • 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):e248-e251. doi: 10.1111/ijlh.13462. Epub 2021 Jan 12. No abstract available.

    PMID: 33433957RESULT

  • 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.

    PMID: 28761292RESULT

  • 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 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: 19357707RESULT

  • 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.

    PMID: 28495498RESULT

  • 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.

    PMID: 32272980RESULT

MeSH Terms

Conditions

Pemphigus

Condition Hierarchy (Ancestors)

Skin Diseases, VesiculobullousSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Youstina Zaghloul

CONTACT

01002142707yostina.zaghloul@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master degree student

Study Record Dates

First Submitted

February 22, 2024

First Posted

February 29, 2024

Study Start

March 1, 2024

Primary Completion

October 1, 2025

Study Completion

February 1, 2026

Last Updated

February 29, 2024

Record last verified: 2024-02