NCT02237313

Brief Summary

The bullous pemphigoid treatment is based on corticosteroids continued for several years. Pemphigus causes some patients a psychological impact and sometimes major vulnerability that can occur not only at diagnosis but also at later stages of disease progression. Our hypothesis is that these episodes of vulnerability may be under four kinds of factors that may be connected to the plurality of the history of these patients, and the resources they can mobilize throughout this experience, generating inequality in management and "work" around the disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

Geographic Reach
1 country

9 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

September 1, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 11, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

April 20, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2017

Completed
Last Updated

February 5, 2026

Status Verified

February 1, 2026

Enrollment Period

2.2 years

First QC Date

September 1, 2014

Last Update Submit

February 4, 2026

Conditions

PemphigusDermatological Disease

Keywords

psychological supporttherapeutic educationvulnerability of patients

Outcome Measures

Primary Outcomes (1)

  • analysis of vulnerability factors

    evaluation of : perception by the patient of misdiagnosis, perception of a possible difference in assessment of the severity of his illness between himself and healthcare professionals, patient behavior in relation to available information sources, and the influence of information gathered on the illness experience, Patient trajectory during the diagnostic phase using individual interview and questionnaire

    12 months

Secondary Outcomes (3)

  • analysis of vulnerability factors

    6 months

  • assessment of anxiety, uncertainty, fear, coping strategies

    12 months

  • assessment of anxiety, uncertainty, fear, coping strategies

    6 months

Study Arms (1)

prevalent cases

EXPERIMENTAL

40 prevalent cases correspond to patients with known pemphigus. Emphasis will be on included patients at different times of the course of their disease. 8 incident cases recruited through the center of Rouen and following an intervention program with psychological support and therapeutic education program

Behavioral: psychological support and therapeutic education program

Interventions

psychological support and therapeutic education programBEHAVIORAL
prevalent cases

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient major
  • Patients with pemphigus vulgaris, diagnosed on a combination of:
  • clinical signs and
  • histological image above basal epithelial detachment with intra acantholysis,
  • direct immunofluorescence showing deposition of Immunoglobulin G and / or C3 to the surface of keratinocytes
  • Join a social security scheme
  • patient has been informed and have signed consent to participate in the study

You may not qualify if:

  • Person placed under judicial protection,
  • Patient without liberty by administrative or judicial decision,
  • Patient participating in another trial for the duration of monitoring.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Hôpital Avicenne

Bobigny, 93000, France

Location

CHU de Clermont-Ferrand Hôpital d'Estaing

Clermont-Ferrand, 63003, France

Location

CH du Mans

Le Mans, 72037, France

Location

CHRU de Lille Hôpital Claude Huriez

Lille, 59037, France

Location

Hôpital La Timone, Assistance publique hôpitaux de Marseille-Aix

Marseille, France

Location

Hôpital Haut-Lévêque

Pessac, 33604, France

Location

Centre hospitalier de Cornouaille

Quimper, 29107, France

Location

Hôpital Robert Debré, chu de Reims

Reims, 51 092, France

Location

University Hospital of Rouen

Rouen, 76031, France

Location

MeSH Terms

Conditions

PemphigusSkin Diseases

Condition Hierarchy (Ancestors)

Skin Diseases, VesiculobullousSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Pascal Joly, Professor

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2014

First Posted

September 11, 2014

Study Start

April 20, 2015

Primary Completion

July 3, 2017

Study Completion

July 3, 2017

Last Updated

February 5, 2026

Record last verified: 2026-02

Locations

FR(9)