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临床试验/NCT03856840
NCT03856840已完成不适用

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

Mahmut Can Koska2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2018年1月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
21
试验地点
2
主要终点
Titers of Anti-BP180-NC18A IgG in blister fluid and blood serum

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Titers of Anti-BP180-NC18A IgG in blister fluid and blood serum

时间窗: 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.

Titers of Eosinophil Cationic Protein in blister fluid and blood serum

时间窗: 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.

Titers of Tumor Necrosis Factor-alpha in blister fluid and blood serum

时间窗: 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.

次要结局

  • Consolidation phase of Outcome Measures for Bullous Pemphigoid(14 days)
  • Time to control of disease activity(Up to 4 weeks)
  • Bullous Pemphigoid Disease Area Index (B.P.D.A.I.)-Pruritus score(Up to one year)
  • Bullous Pemphigoid Disease Area Index (B.P.D.A.I.)(Up to one year)
  • Bullous Pemphigoid Disease Area Index (B.P.D.A.I.)-Damage score(Up to one year)
  • Treatment Failure(4 week)
  • Relapse/Flare(Up to one year)
  • Bullous Pemphigoid disease severity assessment(One day)

研究者

发起方
Mahmut Can Koska
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mahmut Can Koska

Assistant Doctor

Istanbul Medeniyet University

研究点 (2)

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