Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT06903494
Eligibility Criteria:
Inclusion Criteria:
1. 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)
2. Patient who has been informed
3. 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.
4. Patient who has agreed to be monitored and treated according to the revised PNDS
Exclusion Criteria:
1. Patient âgé de moins de 18 ans
2. Diagnostic de Pemphigus (PV) ou (PS) restant incertain
3. Pemphigus paranéoplasique
4. Malade opposé à sa participation ou ne pouvant être suivi régulièrement
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06903494
Study Brief:
Protocol Section:
NCT06903494