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

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ClinicalTrials.gov Identifier: NCT03856840
Recruitment Status : Recruiting
First Posted : February 27, 2019
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Mahmut Can Koska, Istanbul Medeniyet University

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.

Condition or disease
Pemphigoid, Bullous

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 40 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Evaluation of Cytokines and Immunoglobulins in Serum and Blister Fluids Appeared Before Treatment and Subsequently Under Treatment in Bullous Pemphigoid
Actual Study Start Date : January 29, 2018
Estimated Primary Completion Date : June 17, 2019
Estimated Study Completion Date : June 17, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pemphigus

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.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Biospecimen Retention:   Samples Without DNA

Blister Fluid: Blister fluids will be obtained from all enrolled patients in specific three intervals: Before treatment, 4-7. and 8-14. days of treatment in 24 hours after they appear.

Bullae of only one individual day will be selected for each interval to study if they appeared.

Blood Serum: Blood serum will be obtained from all enrolled patients before treatment, seventh day of treatment and fourteen day of treatment.

Obtaining blood serum from patients was added to study afterward. New ethical committee approval was received for that modification in recruitment status at May 17, 2018. Thus blood serum weren't obtained patients who were recruited before that approval. But other specimens obtained from these patients will be included study.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03856840


Contacts
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Contact: Mahmut Can Koska, Assistant Doctor +905396860986 cankoska90@gmail.com

Locations
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Turkey
Istanbul Medeniyet University Goztepe Training and Research Hospital Recruiting
Istanbul, Kadikoy, Turkey, 37722
Contact: Mahmut Can Koska, Assistant Doctor    +905396860986    cankoska90@gmail.com   
Principal Investigator: Mehmet Salih Gurel, Professor         
Sub-Investigator: Mahmut Can Koska, Assistant Doctor         
Sub-Investigator: Hayriye Erman, Assistant Professor         
Istanbul Training and Research Hospital Recruiting
İstanbul, Samatya, Turkey, 34098
Contact: Mehmet Salih Gurel    +905323812204    msgurel@gmail.com   
Principal Investigator: Mehmet Salih Gurel, Professor         
Sub-Investigator: Mahmut Can Koska, Assistant Doctor         
Sponsors and Collaborators
Mahmut Can Koska
Investigators
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Study Director: Mehmet Salih Gurel, Professor Istanbul Medeniyet University

Additional Information:

Publications:

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Responsible Party: Mahmut Can Koska, Assistant Doctor, Istanbul Medeniyet University
ClinicalTrials.gov Identifier: NCT03856840     History of Changes
Other Study ID Numbers: 2018/0181
First Posted: February 27, 2019    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mahmut Can Koska, Istanbul Medeniyet University:
Pemphigoid, Bullous
Bullous Pemphigoid
Blister Fluid
Eosinophil Cationic Protein
Tumor Necrosis Factor-alpha
Anti-BP180
Disease activity
Disease severity

Additional relevant MeSH terms:
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Pemphigoid, Bullous
Blister
Skin Diseases, Vesiculobullous
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Pathological Conditions, Anatomical