Cytokines in Blister Fluids of Bullous Pemphigoid (BP) (BP)

October 2, 2019 updated by: Mahmut Can Koska

Evaluation of Cytokines and Immunoglobulins in Serum and Blister Fluids Appeared Before Treatment and Subsequently Under Treatment in Bullous Pemphigoid

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Kadikoy
      • Istanbul, Kadikoy, Turkey, 37722
        • Istanbul Medeniyet University Goztepe Training and Research Hospital
    • Samatya
      • İstanbul, Samatya, Turkey, 34098
        • Istanbul Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All Bullous Pemphigoid patients presented to concerning clinics who accept the terms and definitions and sign consent form.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Bullous Pemphigoid Patients
Bullae and blood serum, which are obtained before and under treatment, will be compared in each other regardless of any condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Titers of Eosinophil Cationic Protein in blister fluid and blood serum
Time Frame: 14 Days
Calculated of measurements of Eosinophil Cationic Protein (pg/ml) by ELISA technique in blister fluids and serums that obtained before treatment and under first and second weeks of treatment.
14 Days
Titers of Tumor Necrosis Factor-alpha in blister fluid and blood serum
Time Frame: 14 Days
Calculated of measurements of Tumor Necrosis Factor-alpha (pg/ml) by ELISA technique in blister fluids and serums that obtained before treatment and under first and second weeks of treatment.
14 Days
Titers of Anti-BP180-NC18A IgG in blister fluid and blood serum
Time Frame: 14 Days
Calculated of measurements of Anti-BP180-NC18A IgG (U/ml) by ELISA technique in blister fluids and serums that obtained before treatment and under first and second weeks of treatment.
14 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to control of disease activity
Time Frame: Up to 4 weeks
Time interval between initiation of treatment and control of disease activity/beginning of consolidation phase
Up to 4 weeks
Consolidation phase of Outcome Measures for Bullous Pemphigoid
Time Frame: 14 days
Time interval between control of disease activity and end of consolidation phase.
14 days
Treatment Failure
Time Frame: 4 week
Development of nontransient lesions that heal in more than one week, continued extension of old lesions, failure of established lesions to begin to heal or continued pruritus despite of Treatment of one month.
4 week
Relapse/Flare
Time Frame: Up to one year
Appearance of more than three lesions per month or at least one large eczematous lesion or urticarial plaques that do not heal within one week, or extension of established lesions or daily pruritus in patient who was achieved disease control
Up to one year
Bullous Pemphigoid disease severity assessment
Time Frame: One day

This assessment will depend on multiple factors according to more than one classification. Patients will be separated to mild, moderate, severe conditions according to their clinical findings.

Mild: Involvement of less than %10 of skin surface area and appearance of less than 10 bullae in each day. Both feature will be necessary to regard individual patient's disease as mild.

Moderate: Involvement of %10-30 of skin surface area and appearance of less than 10 bullae in each day. Both feature will be necessary to regard individual patient's disease as moderate.

Severe: Involvement of more than %30 of skin surface area or appearance of more than 10 bullae in each day or B.P.D.A.I. score more than 56 (without Visual analogue score of pruritus). Existence of even one of this findings will ve sufficient to regard individual patient's disease as severe.

One day
Bullous Pemphigoid Disease Area Index (B.P.D.A.I.)
Time Frame: Up to one year

BPDAI is an index to assess disease area and severity depending on involvement of mucosa and skin region, lesion number and size. Minimum score is 0 and maximum score is 360.

This index will be calculated at before treatment, second week and fourth week of treatment. After first month it will be calculated in each follow-up visit.

Up to one year
Bullous Pemphigoid Disease Area Index (B.P.D.A.I.)-Damage score
Time Frame: Up to one year

Scars of previous lesions are also included to this index, minimum score is 0 and maximum score is 12.

This index will be calculated at before treatment, second week and fourth week of treatment. After first month it will be calculated in each follow-up visit.

Up to one year
Bullous Pemphigoid Disease Area Index (B.P.D.A.I.)-Pruritus score
Time Frame: Up to one year

Visual analogue score of pruritus is also part of this index. Minimum score is 0 and maximum score is 10. This score will be assessed for last 24 hours, last one week, last one month one by one; thus maximum score will be 30.

This index will be calculated at before treatment, second week and fourth week of treatment. After first month it will be calculated in each follow-up visit.

Up to one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Mehmet Salih Gurel, Professor, Istanbul Medeniyet University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 29, 2018

Primary Completion (Actual)

May 23, 2019

Study Completion (Actual)

August 27, 2019

Study Registration Dates

First Submitted

February 19, 2019

First Submitted That Met QC Criteria

February 26, 2019

First Posted (Actual)

February 27, 2019

Study Record Updates

Last Update Posted (Actual)

October 4, 2019

Last Update Submitted That Met QC Criteria

October 2, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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