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

January 4, 2019 updated by: University Hospital, Brest

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

63

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

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

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 with a new diagnosis of bullous pemphigoid

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnant woman
  • nursing women

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical characteristics of pruritus in patients with bullous pemphigoid
Time Frame: Day1 ( when diagnosis of bullous pemphigoid is made)
Answers and scores in questionnaire about clinical characteristics of pruritus Demographics characteristics of patients Characteristics of the bullous pemphigoid
Day1 ( when diagnosis of bullous pemphigoid is made)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of pruritus on quality of life in patients with bullous pemphigoid
Time Frame: Day 1 (when diagnosis of bullous pemphigoid is made )
Score 5D itch scale
Day 1 (when diagnosis of bullous pemphigoid is made )
Impact of pruritus on quality of life in patients with bullous pemphigoid
Time Frame: Day1 (when diagnosis of bullous pemphigoid is made )
score ItchyQol (Itchy Quality of Life)
Day1 (when diagnosis of bullous pemphigoid is made )
Impact of pruritus on quality of life in patients with bullous pemphigoid
Time Frame: Day 1 (when diagnosis of bullous pemphigoid is made )
score ABQOL
Day 1 (when diagnosis of bullous pemphigoid is made )

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

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)

November 7, 2017

Primary Completion (ACTUAL)

October 3, 2018

Study Completion (ACTUAL)

October 3, 2018

Study Registration Dates

First Submitted

July 21, 2017

First Submitted That Met QC Criteria

September 3, 2017

First Posted (ACTUAL)

September 6, 2017

Study Record Updates

Last Update Posted (ACTUAL)

January 7, 2019

Last Update Submitted That Met QC Criteria

January 4, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29BRC17.0066 ( PRURIPB)

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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