Clinical Characteristics of Pruritus and Evaluation of Quality of Life in Patients With Bullous Pemphigoid
PRURIPB
1 other identifier
observational
63
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2017
Shorter than P25 for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2017
CompletedFirst Posted
Study publicly available on registry
September 6, 2017
CompletedStudy Start
First participant enrolled
November 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 3, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 3, 2018
CompletedJanuary 7, 2019
January 1, 2019
11 months
July 21, 2017
January 4, 2019
Conditions
Keywords
Outcome Measures
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
Day1 ( when diagnosis of bullous pemphigoid is made)
Secondary Outcomes (3)
Impact of pruritus on quality of life in patients with bullous pemphigoid
Day 1 (when diagnosis of bullous pemphigoid is made )
Impact of pruritus on quality of life in patients with bullous pemphigoid
Day1 (when diagnosis of bullous pemphigoid is made )
Impact of pruritus on quality of life in patients with bullous pemphigoid
Day 1 (when diagnosis of bullous pemphigoid is made )
Eligibility Criteria
All patients with a new diagnosis of bullous pemphigoid
You may qualify if:
- adult
- pruriginous bullous pemphigoid lately diagnosed.
- Without PB treatment
- MMS (Mini Mental State Examination) ≥ 21
- In hospitalization or consultation
You may not qualify if:
- pregnant woman
- nursing women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
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-Etienne, 42055, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2017
First Posted
September 6, 2017
Study Start
November 7, 2017
Primary Completion
October 3, 2018
Study Completion
October 3, 2018
Last Updated
January 7, 2019
Record last verified: 2019-01