NCT Number: NCT02237313
Identification of Vulnerability Factors in the Course of Pemphigus Patients
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.
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Hôpital Avicenne, Bobigny, France
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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
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.
Treatment and study plan
Primary outcomes
-
analysis of vulnerability factors
Time frame: 12 months
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
Secondary outcomes
-
analysis of vulnerability factors
Time frame: 6 months
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
-
assessment of anxiety, uncertainty, fear, coping strategies
Time frame: 12 months
assessment of anxiety, uncertainty, fear, coping strategies using individual interview and questionnaire
-
assessment of anxiety, uncertainty, fear, coping strategies
Time frame: 6 months
assessment of anxiety, uncertainty, fear, coping strategies using individual interview and questionnaire
Sponsors and collaborators
Lead sponsor
University Hospital, Rouen
Other
Registry information
Official study title
Identification of Vulnerability Factors in the Course of Pemphigus Patients - SHS Pemphigus Clinical Trial
Acronym: SHS-Pemphigus
Important dates
- Study start
- 2015
- Primary completion
- 2017
- Study completion
- 2017
- First posted
- Sep 11, 2014
- Registry last updated
- Feb 5, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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