ClinicalTrials.gg
CompletedNCT03320798Updated Oct 25, 2017

Impact of Neurological Diseases on the Prognosis of Bullous Pemphigoid: A Retrospective Study of 178 Patients

An observational study in Bullous Pemphigoid, sponsored by CHU de Reims. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-25.

Sponsored by CHU de Reims · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
178
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 28 studies in Pemphigoid, Bullous with a site in France — 5 open to participants now, 6 under way, 1 of them phase 3. Pemphigoid, Bullous · France.

Enrollment
3rd of 11
178 · median 122
Started
2013
with 3 others
Observational
11 of 28
1 open now
Registered
13th of 28
by date
Lead sponsor
6 of 28
CHU de Reims

Among the 28 studies in Pemphigoid, Bullous with a site in France, this one is the 3rd largest by enrollment of the 11 observational ones that give a count, is one of 4 that started in 2013, is one of 11 observational ones, and was the 13th registered.

Pemphigoid, Bullous

64 studies on the registry are indexed under Pemphigoid, Bullous; 8 are open to participants now.

Browse Pemphigoid, Bullous studies →

Open to participants now

5 of the 28 studies in Pemphigoid, Bullous with a site in France are open now. Recruiting first, the newest first:

All 5 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 5 Pemphigoid, Bullous studies recruiting now, 3 set no upper age limit and none stop at 75 or younger; 1 takes children under 18; none take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

Bullous pemphigoid affects mainly elderly patients. It is often associated with neurologic disorders, which represent a major risk factor of the disease

Read the detailed description

The aim was to determine whether neurologic disorders, especially dementia, influences outcome and mortality of patients with bullous pemphigoid.

03

Conditions studied

  • Bullous Pemphigoid

Keywords

  • Bullous pemphigoid
  • neurologic disorders
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Eligibility criteria

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 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
178 participants (actual)
Patient registry
No

Groups and cohorts

  • group "Bullous pemphigoid"

    Patients consulting at dermatology department of Reims Teaching Hospital for bullous pemphigoid between 1997 and 2011.

    Other: Data record

Interventions

  • OtherData record
06

What researchers measure

Primary outcomes

  1. neurological disease

    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.

    Time frame: Day 0

07

Study locations

1 site
  • Damien JOLLY
    Reims, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2013 to primary completion in Oct 2014, 12 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 23, 2017
First posted
Oct 25, 2017
StartActual
Oct 1, 2013
Primary completionActual
Oct 1, 2014
CompletionActual
Mar 1, 2015
Last update
Oct 25, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 25, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03320798
Lead sponsor
CHU de Reims
Responsible party
Sponsor
First posted
Oct 25, 2017
Start date
Oct 1, 2013
Primary completion
Oct 1, 2014
Completion
Mar 1, 2015
Last update
Oct 25, 2017

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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