PemphigusSHS-PemphigusNCT02237313
Identification of Vulnerability Factors in the Course of Pemphigus Patients
A study testing psychological support and therapeutic education program in people with Pemphigus and Dermatological Disease, run by University Hospital, Rouen at 9 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pemphigus, Dermatological Disease
- What is being tested?
- psychological support and therapeutic education program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 9 sitesFrance
- Study dates
- 20 Apr 2015to 3 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Person placed under judicial protection,
- Patient without liberty by administrative or judicial decision,
- Patient participating in another trial for the duration of monitoring.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Hôpital Avicenne
Bobigny, 93000
CHU de Clermont-Ferrand Hôpital d'Estaing
Clermont-Ferrand, 63003
CH du Mans
Le Mans, 72037
CHRU de Lille Hôpital Claude Huriez
Lille, 59037
Hôpital La Timone, Assistance publique hôpitaux de Marseille-Aix
Marseille
Hôpital Haut-Lévêque
Pessac, 33604
Centre hospitalier de Cornouaille
Quimper, 29107
Hôpital Robert Debré, chu de Reims
Reims, 51 092
University Hospital of Rouen
Rouen, 76031
About this study
Official title: Identification of Vulnerability Factors in the Course of Pemphigus Patients - SHS Pemphigus Clinical Trial
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.
Read the detailed description
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
- Pemphigus, Dermatological Disease
- Being tested
- psychological support and therapeutic education program
- Keywords
- psychological support, therapeutic education, vulnerability of patients
- Medical subject headings
- Pemphigus, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychological support and therapeutic education programBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: psychological support and therapeutic education program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (3)
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
Measured: 6 months
assessment of anxiety, uncertainty, fear, coping strategies
assessment of anxiety, uncertainty, fear, coping strategies using individual interview and questionnaire
Measured: 12 months
assessment of anxiety, uncertainty, fear, coping strategies
assessment of anxiety, uncertainty, fear, coping strategies using individual interview and questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2014 (estimated)
- Study start20 Apr 2015
- Primary completion3 Jul 2017
- Study completion3 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PemphigusStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal Joly, Professor, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02237313
- Sponsor's protocol ID
- 2014/063/HP
- Other IDs
- 2014A0067740
- Acronym
- SHS-Pemphigus
- Status last verified
- Feb 2026
- First submitted
- 1 Sep 2014
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Vulnerability Factors in the Course of Pemphigus Patients - SHS Pemphigus Clinical Trial
- ClinicalTrials.gov ID
- NCT02237313
- Acronym / sponsor ID
- SHS-Pemphigus / 2014/063/HP
- Conditions
- Pemphigus, Dermatological Disease
- Keywords
- psychological support, therapeutic education, vulnerability of patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 20 Apr 2015 (actual)
- Primary completion
- 3 Jul 2017 (actual)
- Study completion
- 3 Jul 2017 (actual)
- First posted
- 11 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| prevalent cases | Experimental | Behavioral: psychological support and therapeutic education program40 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient major
- Patients with pemphigus vulgaris, diagnosed on a combination of:
- Join a social security scheme
- patient has been informed and have signed consent to participate in the study
Key exclusion criteria (3 listed)
- Person placed under judicial protection,
- Patient without liberty by administrative or judicial decision,
- Patient participating in another trial for the duration of monitoring.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| psychological support and therapeutic education program | Behavioural | prevalent cases |
Primary outcome
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
3 secondary outcomes
analysis of vulnerability factors
Time frame: 6 months
assessment of anxiety, uncertainty, fear, coping strategies
Time frame: 12 months
assessment of anxiety, uncertainty, fear, coping strategies
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pascal Joly, Professor principal investigator
University Hospital, Rouen
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing psychological support and therapeutic education program in people with Pemphigus and Dermatological Disease, run by University Hospital, Rouen at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
analysis of vulnerability factors (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.