Identification of Vulnerability Factors in the Course of Pemphigus Patients

NCT ID: NCT02237313

Last Updated: 2026-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-20

Study Completion Date

2017-07-03

Brief Summary

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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.

Detailed Description

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The originality of the project lies in its multidisciplinary approach (dermatology, psychology, sociology). No such study has yet been carried out in the pemphigus who has been the subject of a very small number of works in sociology or psychology. The only studies are studies of quality of life with no longitudinal follow-up. The perspective of qualitative and quantitative data, sociological and psychological approaches, should allow more innovative and adapted to the medico-social and psychological care of patients with pemphigus approaches. The purpose of this study is to identify the determinants leading to moments of vulnerability in the course of patients with pemphigus in order to be able to offer preventive or corrective actions to improve the experience of the disease.

Conditions

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Pemphigus Dermatological Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Study Groups

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prevalent cases

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

Group Type EXPERIMENTAL

psychological support and therapeutic education program

Intervention Type BEHAVIORAL

Interventions

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psychological support and therapeutic education program

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Patient major
* Patients with pemphigus vulgaris, diagnosed on a combination of:

1. clinical signs and
2. histological image above basal epithelial detachment with intra acantholysis,
3. 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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pascal Joly, Professor

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

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Hôpital Avicenne

Bobigny, , France

Site Status

CHU de Clermont-Ferrand Hôpital d'Estaing

Clermont-Ferrand, , France

Site Status

CH du Mans

Le Mans, , France

Site Status

CHRU de Lille Hôpital Claude Huriez

Lille, , France

Site Status

Hôpital La Timone, Assistance publique hôpitaux de Marseille-Aix

Marseille, , France

Site Status

Hôpital Haut-Lévêque

Pessac, , France

Site Status

Centre hospitalier de Cornouaille

Quimper, , France

Site Status

Hôpital Robert Debré, chu de Reims

Reims, , France

Site Status

University Hospital of Rouen

Rouen, , France

Site Status

Countries

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France

Other Identifiers

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2014A0067740

Identifier Type: REGISTRY

Identifier Source: secondary_id

2014/063/HP

Identifier Type: -

Identifier Source: org_study_id

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