Cytokines in Blister Fluids of Bullous Pemphigoid (BP)

NCT ID: NCT03856840

Last Updated: 2019-10-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 21 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-29
• Study Completion Date: 2019-08-27

Brief Summary

This study investigates the differences of Eosinophil Cationic Protein, Tumor Necrosis Factor-alpha and Anti-BP180-NC16A IgG levels of blister fluids in Bullous Pemphigoid patients which appeared before and under treatment subsequently. These molecules will also be measured in blood serum before and under treatment. Changes of titers in serum and differences between blister fluids will be compared to observe whether correlation exists between them. These measures will also be compared between groups of responders and non-responders to the first-line treatment options to analyze correlation with treatment success.

Detailed Description

Bullous Pemphigoid is an auto-immune bullous disorder in which auto-antibodies to hemidesmosomes, complement pathway, inflammatory cells and mediators play a crucial roles for disease pathogenesis.

Anti-BP180-NC16A IgG is an antibody that it primarily triggers inflammatory reactions and complement cascade in bullae development and plays major roles in disease pathogenesis. It is secreted by plasma cells which is induced by T-helper 2 cells and their cytokines in serum and lesional tissue. Anti-BP180 antibody detection in serum is very important in diagnosis and titers correlate with disease activity. Anti-BP180 antibody can also be detected in blister fluids and it may aid diagnosis.

Eosinophil cationic Protein is a cytokine and secreted by Eosinophil which is found in abundant numbers and correlated with tissue damage in Bullous Pemphigoid lesions. Serum titers of Eosinophil Cationic Protein has a correlation with disease activity and it is higher in blister fluid than serum. Tumor Necrosis Factor-alpha is an another cytokine which is secreted from inflammatory cells initially after inflammatory cascade is triggered. It is also found increased in serum blister fluids. Tumor necrosis factor-alpha is associated with clinical severity in bullous pemphigoid.

In Bullous Pemphigoid, development of bulla is required to be stopped if treatment will be considered as successful. Nevertheless smaller, more rapidly healing vesicles and bullae appear under treatment which are not regarded as findings of treatment failure. In this study we will measure Eosinophil Cationic Protein, Tumor Necrosis Factor-alpha and Anti-BP180-NC16A IgG levels with E.L.I.S.A. technique in these subsequently appeared blisters if they will appear and compare them with pretreatment blisters. We will also measure levels of these molecules in blood serum before and under treatment. We will analyze corralation between blood serum and blister fluids. Also we will compare responder patients and non-responder patients to first-line treatment options to observe correlation of changes and differences in these body fluids with treatment success.

Conditions

Pemphigoid, Bullous

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Bullous Pemphigoid Patients

Bullae and blood serum, which are obtained before and under treatment, will be compared in each other regardless of any condition.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• All patiens presented to clinics who is diagnosed with Bullous Pemphigoid by findings of clinical, histopathological, Direct Immunoflorescent evaluation.
• All relapsed/flared Bullous Pemphigoid patients.
• Patients who accept the terms and conditions and sign consent form.

Exclusion Criteria

• Patients who are received treatment before presenting clinics where the study is conducted.
• Patients who reject to join to study and the terms and condition
• Patients who leave the study by own decision

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mahmut Can Koska

OTHER

Sponsor Role: lead

Responsible Party

Mahmut Can Koska

Assistant Doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mehmet Salih Gurel, Professor

Role: STUDY_DIRECTOR

Istanbul Medeniyet University

Locations

Istanbul Medeniyet University Goztepe Training and Research Hospital

Istanbul, Kadikoy, Turkey (Türkiye)

Istanbul Training and Research Hospital

Istanbul, Samatya, Turkey (Türkiye)

Countries

Turkey (Türkiye)

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Other Identifiers

2018/0181

Identifier Type: -

Identifier Source: org_study_id