Skip to main content
OpenTrials
Completed

NCT Number: NCT03856840

Cytokines in Blister Fluids of Bullous Pemphigoid (BP)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pemphigoid, Bullous Autoimmune Diseases Immune System Diseases Skin Diseases Skin Diseases, Vesiculobullous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Medeniyet University Goztepe Training and Research Hospital, Istanbul, Kadikoy, Turkey (Türkiye)

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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

  2. Consolidation phase of Outcome Measures for Bullous Pemphigoid

    Time frame: 14 days

    Time interval between control of disease activity and end of consolidation phase.

  3. 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. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Mahmut Can Koska

Other

Registry information

Official study title

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

Acronym: BP

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 27, 2019
Registry last updated
Oct 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.