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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03272958
Other study ID # 29BRC17.0066 ( PRURIPB)
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 7, 2017
Est. completion date October 3, 2018

Study information

Verified date January 2019
Source University Hospital, Brest
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 63
Est. completion date October 3, 2018
Est. primary completion date October 3, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
France CH Argenteuil Argenteuil
France AP-HP, Hôpital Avicenne Bobigny
France CHU de Bordeaux Bordeaux
France CHRU de Brest Brest
France CHU Caen Caen
France CHU de Clermont-Ferrand Clermont-Ferrand
France AP-HP, Hôpital Henri Mondor Créteil
France CHU Le Havre Le Havre
France HP-HM Marseille
France CHU de Montpellier Montpellier
France CH de Niort Niort
France AP-HP, Hôpital Bichat Paris
France AP-HP, Hôpital Cochin Paris
France CHU de Reims Reims
France CHU de Rouen Rouen
France CHU de Saint-Etienne Saint-Étienne

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Impact of pruritus on quality of life in patients with bullous pemphigoid Score 5D itch scale Day 1 (when diagnosis of bullous pemphigoid is made )
Secondary Impact of pruritus on quality of life in patients with bullous pemphigoid score ItchyQol (Itchy Quality of Life) Day1 (when diagnosis of bullous pemphigoid is made )
Secondary Impact of pruritus on quality of life in patients with bullous pemphigoid score ABQOL Day 1 (when diagnosis of bullous pemphigoid is made )
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