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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 : Recruiting
First Posted : September 6, 2017
Last Update Posted : March 7, 2018
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

Study Type : Observational
Estimated Enrollment : 50 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
Estimated Primary Completion Date : November 7, 2018
Estimated Study Completion Date : November 7, 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


Contacts
Contact: Laurent Misery 02-98-22-33-15 laurent.misery@chu-brest.fr
Contact: Emilie Brenaut emilie.brenaut@chu-brest.fr

Locations
France
CH Argenteuil Not yet recruiting
Argenteuil, France, 95100
Contact: Emmanuel MAHE         
AP-HP, Hôpital Avicenne Not yet recruiting
Bobigny, France, 93009
Contact: Frédéric CAUX         
CHU de Bordeaux Not yet recruiting
Bordeaux, France, 33404
Contact: Marie-Sylvie DOUTRE         
CHRU de Brest Recruiting
Brest, France, 29609
Contact: Laurent Misery       laurent.misery@chu-brest.fr   
Contact: Emilie BRENAUT       emilie.brenaut@chu-brest.fr   
CHU Caen Not yet recruiting
Caen, France, 14033
Contact: Laurence VERNEUIL         
CHU de Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Michel D'INCAN         
AP-HP, Hôpital Henri Mondor Recruiting
Créteil, France, 94000
Contact: Saskia ORO         
CHU Le Havre Not yet recruiting
Le Havre, France, 76083
Contact: Noémie LOTROWSKI         
HP-HM Not yet recruiting
Marseille, France, 13385
Contact: Marie-Aleth Richard         
CHU de Montpellier Not yet recruiting
Montpellier, France, 34295
Contact: Olivier DEREURE         
CH de Niort Not yet recruiting
Niort, France, 79021
Contact: Ingrid KUPFER-BESSAGUET         
AP-HP, Hôpital Cochin Not yet recruiting
Paris, France, 75006
Contact: Vannina SETA         
AP-HP, Hôpital Bichat Not yet recruiting
Paris, France, 75018
Contact: Catherine PICARD         
CHU de Reims Not yet recruiting
Reims, France, 51092
Contact: Philippe BERNARD         
CHU de Rouen Not yet recruiting
Rouen, France, 76031
Contact: Pascal JOLY         
CHU de Saint-Etienne Not yet recruiting
Saint-Étienne, France, 42055
Contact: Bruno LABEILLE         
Sponsors and Collaborators
University Hospital, Brest

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: March 7, 2018
Last Verified: March 2018

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
Skin Diseases
Skin Manifestations
Signs and Symptoms
Skin Diseases, Vesiculobullous
Autoimmune Diseases
Immune System Diseases