Status:
COMPLETED
Assessment of the 1-year Relapse Rate in Patients with Pemphigus Treated According to the Revised Pemphigus PNDS
Lead Sponsor:
University Hospital, Rouen
Conditions:
Dermatology Disease
Eligibility:
All Genders
18+ years
Brief Summary
In May 2018, the PNDS (national diagnosis and care protocol) for pemphigus drawn up by the autoimmune bullous diseases reference centre was amended to take into account the results of recent studies a...
Detailed Description
Pemphigus is a rare, potentially life-threatening autoimmune bullous disease affecting both the skin and mucous membranes in which pathogenic IgG antibodies are directed against desmosomal transmembra...
Eligibility Criteria
Inclusion
- Pemphigus newly diagnosed according to the following criteria:
- erosions and/or superficial cutaneous and/or mucosal bullae, suggestive of pemphigus vulgaris (PV) or pemphigus superficialis (PS)
- histological appearance of intraepidermal acantholysis
- IgG and/or C3 deposits on the keratinocyte membrane (after meshwork)
- Patient who has been informed
- Moderate to severe pemphigus (PDAI score \> 15), or mild pemphigus (PDAI score ≤ 15) that has not responded to the 1st line of treatment recommended in the NDSP (local corticosteroid therapy ± disulone) after three months.
- Patient who has agreed to be monitored and treated according to the revised PNDS
Exclusion
- Patient âgé de moins de 18 ans
- Diagnostic de Pemphigus (PV) ou (PS) restant incertain
- Pemphigus paranéoplasique
- Malade opposé à sa participation ou ne pouvant être suivi régulièrement
Key Trial Info
Start Date :
February 17 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06903494
Start Date
February 17 2021
End Date
March 1 2025
Last Update
March 30 2025
Active Locations (1)
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1
Pascal
Rouen, France, 76031