- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03320798
Impact of Neurological Diseases on the Prognosis of Bullous Pemphigoid: A Retrospective Study of 178 Patients
October 23, 2017 updated by: CHU de Reims
Bullous pemphigoid affects mainly elderly patients.
It is often associated with neurologic disorders, which represent a major risk factor of the disease
Study Overview
Detailed Description
The aim was to determine whether neurologic disorders, especially dementia, influences outcome and mortality of patients with bullous pemphigoid.
Study Type
Observational
Enrollment (Actual)
178
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
-
-
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Reims, France
- Damien JOLLY
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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 patients presenting bullous pemphigoid and consulting at dermatology department of Reims Teaching Hospital (France) between 1997 and 2011.
Description
Inclusion Criteria:
- patients presenting bullous pemphigoid using the following criteria: clinical features typical of BP with presence of at least three out of four well-established criteria of Vaillant et al., subepidermal blister on skin biopsy and deposits of IgG and/or C3 in a linear pattern along the epidermal basement membrane zone by direct IF
- patients consulting at dermatology department of Reims Teaching Hospital (France) between 1997 and 2011
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
group "Bullous pemphigoid"
Patients consulting at dermatology department of Reims Teaching Hospital for bullous pemphigoid between 1997 and 2011.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
neurological disease
Time Frame: Day 0
|
neurological disease are dementia (Alzheimers disease or other dementia), Parkinson's syndrome and stroke.
Diagnosis of dementia was carried out in several ways: after examination by a neurologist or geriatrician, when the Mini Mental State was less than or equal to 17 or in the presence of a demonstrated and clinically evident dementia.
|
Day 0
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
October 1, 2013
Primary Completion (Actual)
October 1, 2014
Study Completion (Actual)
March 1, 2015
Study Registration Dates
First Submitted
October 23, 2017
First Submitted That Met QC Criteria
October 23, 2017
First Posted (Actual)
October 25, 2017
Study Record Updates
Last Update Posted (Actual)
October 25, 2017
Last Update Submitted That Met QC Criteria
October 23, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016Ao004
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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