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

Sponsor
University Hospital, Brest (Other)
Overall Status
Completed
CT.gov ID
NCT03272958
Collaborator
(none)
63
Enrollment
16
Locations
10.8
Actual Duration (Months)
3.9
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    63 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Clinical Characteristics of Pruritus and Evaluation of Quality of Life in Patients With Bullous Pemphigoid
    Actual Study Start Date :
    Nov 7, 2017
    Actual Primary Completion Date :
    Oct 3, 2018
    Actual Study Completion Date :
    Oct 3, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Clinical characteristics of pruritus in patients with bullous pemphigoid [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

    Secondary Outcome Measures

    1. Impact of pruritus on quality of life in patients with bullous pemphigoid [Day 1 (when diagnosis of bullous pemphigoid is made )]

      Score 5D itch scale

    2. Impact of pruritus on quality of life in patients with bullous pemphigoid [Day1 (when diagnosis of bullous pemphigoid is made )]

      score ItchyQol (Itchy Quality of Life)

    3. Impact of pruritus on quality of life in patients with bullous pemphigoid [Day 1 (when diagnosis of bullous pemphigoid is made )]

      score ABQOL

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CH Argenteuil Argenteuil France 95100
    2 AP-HP, Hôpital Avicenne Bobigny France 93009
    3 CHU de Bordeaux Bordeaux France 33404
    4 CHRU de Brest Brest France 29609
    5 CHU Caen Caen France 14033
    6 CHU de Clermont-Ferrand Clermont-Ferrand France 63003
    7 AP-HP, Hôpital Henri Mondor Créteil France 94000
    8 CHU Le Havre Le Havre France 76083
    9 HP-HM Marseille France 13385
    10 CHU de Montpellier Montpellier France 34295
    11 CH de Niort Niort France 79021
    12 AP-HP, Hôpital Cochin Paris France 75006
    13 AP-HP, Hôpital Bichat Paris France 75018
    14 CHU de Reims Reims France 51092
    15 CHU de Rouen Rouen France 76031
    16 CHU de Saint-Etienne Saint-Étienne France 42055

    Sponsors and Collaborators

    • University Hospital, Brest

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Brest
    ClinicalTrials.gov Identifier:
    NCT03272958
    Other Study ID Numbers:
    • 29BRC17.0066 ( PRURIPB)
    First Posted:
    Sep 6, 2017
    Last Update Posted:
    Jan 7, 2019
    Last Verified:
    Jan 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Brest
    Pruritus
    Bullous pemphigoid
    Additional relevant MeSH terms:
    Pruritus
    Pemphigoid, Bullous

    Study Results

    No Results Posted as of Jan 7, 2019