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

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ClinicalTrials.gov Identifier: NCT03272958
Recruitment Status : Completed
First Posted : September 6, 2017
Last Update Posted : January 7, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

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
Bullous Pemphigoid

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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 : November 7, 2017
Actual Primary Completion Date : October 3, 2018
Actual Study Completion Date : October 3, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Itching Pemphigus




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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)

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with a new diagnosis of bullous pemphigoid
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03272958


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

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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT03272958     History of Changes
Other Study ID Numbers: 29BRC17.0066 ( PRURIPB)
First Posted: September 6, 2017    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: January 2019

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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:
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Pruritus
Pemphigoid, Bullous
Skin Diseases
Skin Manifestations
Signs and Symptoms
Skin Diseases, Vesiculobullous
Autoimmune Diseases
Immune System Diseases