ClinicalTrials.gg
CompletedNCT03272958PRURIPBUpdated Jan 7, 2019

Clinical Characteristics of Pruritus and Evaluation of Quality of Life in Patients With Bullous Pemphigoid

An observational study in Bullous Pemphigoid, sponsored by University Hospital, Brest. Completed at 16 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-07.

Sponsored by University Hospital, Brest · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
63
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
9th of 11
63 · median 122
Started
2017
the only one that year
Observational
11 of 28
1 open now
Registered
11th of 28
by date

Among the 28 studies in Pemphigoid, Bullous with a site in France, this one is the 9th largest by enrollment of the 11 observational ones that give a count, is the only one that started in 2017, is one of 11 observational ones, and was the 11th 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

Whereas pruritus is a major symptom in bullous pemphigoid, its characteristics and its impact on quality of life have been little studied.

The objective of this study is to learn more about pruritus characteristics of patients with bullous pemphigoid, and in consequence to better understand the pathophysiology of pruritus, and then to better treat pruritus in this condition.

03

Conditions studied

  • Bullous Pemphigoid

Keywords

  • Pruritus
  • Bullous pemphigoid
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 with a new diagnosis of bullous pemphigoid

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • adult
  • pruriginous bullous pemphigoid lately diagnosed.
  • Without PB treatment
  • MMS () ≥ 21
  • In hospitalization or consultation

Exclusion criteria

Exclusion Criteria:

  • pregnant woman
  • nursing women
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.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
63 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Clinical characteristics of pruritus in patients with bullous pemphigoid

    Answers and scores in questionnaire about clinical characteristics of pruritus Demographics characteristics of patients Characteristics of the bullous pemphigoid

    Time frame: Day1 ( when diagnosis of bullous pemphigoid is made)

Secondary outcomes

  1. Impact of pruritus on quality of life in patients with bullous pemphigoid

    Score 5D itch scale

    Time frame: Day 1 (when diagnosis of bullous pemphigoid is made )

  2. Impact of pruritus on quality of life in patients with bullous pemphigoid

    score ItchyQol (Itchy Quality of Life)

    Time frame: Day1 (when diagnosis of bullous pemphigoid is made )

  3. Impact of pruritus on quality of life in patients with bullous pemphigoid

    score ABQOL

    Time frame: Day 1 (when diagnosis of bullous pemphigoid is made )

07

Study locations

16 sites
  • CH Argenteuil
    Argenteuil, 95100, France
  • AP-HP, Hôpital Avicenne
    Bobigny, 93009, France
  • CHU de Bordeaux
    Bordeaux, 33404, France
  • CHRU de Brest
    Brest, 29609, France
  • CHU Caen
    Caen, 14033, France
  • CHU de Clermont-Ferrand
    Clermont-Ferrand, 63003, France
  • AP-HP, Hôpital Henri Mondor
    Créteil, 94000, France
  • CHU Le Havre
    Le Havre, 76083, France
  • HP-HM
    Marseille, 13385, France
  • CHU de Montpellier
    Montpellier, 34295, France
  • CH de Niort
    Niort, 79021, France
  • AP-HP, Hôpital Cochin
    Paris, 75006, France
  • AP-HP, Hôpital Bichat
    Paris, 75018, France
  • CHU de Reims
    Reims, 51092, France
  • CHU de Rouen
    Rouen, 76031, France
  • CHU de Saint-Etienne
    Saint-Étienne, 42055, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2017 to primary completion in Oct 2018, 10 months.

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

Registered
Jul 21, 2017
First posted
Sep 6, 2017
StartActual
Nov 7, 2017
Primary completionActual
Oct 3, 2018
CompletionActual
Oct 3, 2018
Last update
Jan 7, 2019
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 Jan 7, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03272958
Responsible party
Sponsor
First posted
Sep 6, 2017
Start date
Nov 7, 2017
Primary completion
Oct 3, 2018
Completion
Oct 3, 2018
Last update
Jan 7, 2019

Oversight

Data monitoring committee
No
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 Jan 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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