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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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4 March 2024 |
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Main ID: |
NCT02837965 |
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Date of registration:
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24/06/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Observational Study Assessing Outcomes, Treatment Patterns and Related Costs in Patients in Bullous Pemphigoid
EDP-PB |
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Scientific title:
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Multicenter Prospective Observational Study Assessing Outcomes, Adverse Events, Treatment Patterns and Related Costs in Patients Diagnosed With Bullous Pemphigoid |
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Date of first enrolment:
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September 26, 2013 |
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Target sample size:
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149 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02837965 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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France
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Written informed consent from the patient or a legally authorized representative
person.
- Patients affiliated to social security system
- BP newly diagnosed according to the following criteria: i) suggestive clinical
features; ii) histological picture of subepidermal blisters with an infiltrate of
eosinophils in the superficial dermis; iii) presence of continuous, linear deposits of
IgG and C3 deposits along the skin basement membrane zone by direct IF.
- Patients: no prior superpotent topical steroid therapy or systemic treatment for BP
for more than 2 weeks
Exclusion Criteria:
- BP in relapse
- Pemphigoid of pregnancy
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Bullous Pemphigoid
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Intervention(s)
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Drug: treatment with topical superpotent corticosteroid therapy
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Drug: treatment with systemic therapy (prednisone)
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Drug: treatment with systemic therapy (doxycycline)
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Drug: treatment systemic therapy (prednisone)
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Drug: treatment with systemic therapy (methotrexate)
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Primary Outcome(s)
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BPDAI (bullous pemphigoid disease area index)
[Time Frame: up to one year]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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