NCT03272958

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2017

Shorter than P25 for all trials

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 6, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

November 7, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2018

Completed
Last Updated

January 7, 2019

Status Verified

January 1, 2019

Enrollment Period

11 months

First QC Date

July 21, 2017

Last Update Submit

January 4, 2019

Conditions

Keywords

PruritusBullous pemphigoid

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

AP-HP, Hôpital Avicenne

Bobigny, 93009, France

Location

CHU de Bordeaux

Bordeaux, 33404, France

Location

CHRU de Brest

Brest, 29609, France

Location

CHU Caen

Caen, 14033, France

Location

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

AP-HP, Hôpital Henri Mondor

Créteil, 94000, France

Location

CHU Le Havre

Le Havre, 76083, France

Location

HP-HM

Marseille, 13385, France

Location

CHU de Montpellier

Montpellier, 34295, France

Location

CH de Niort

Niort, 79021, France

Location

AP-HP, Hôpital Cochin

Paris, 75006, France

Location

AP-HP, Hôpital Bichat

Paris, 75018, France

Location

CHU de Reims

Reims, 51092, France

Location

CHU de Rouen

Rouen, 76031, France

Location

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Pemphigoid, BullousPruritus

Condition Hierarchy (Ancestors)

Skin Diseases, VesiculobullousSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

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

Locations