Health Condition 1: null- ORAL PEMPHIGUS VULGARIS
Conditions
Interventions
Intervention1: TOPICAL RITUXIMAB ENCAPSULATED IN NANOPARTICLE: RITUXIMAB IS ANTI CD 20 MONOCLONAL ANTIBODY USED IN PEMPHIGUS VULGARIS AS INTRAVENOUS INFUSION. WE ARE MAKING TOPICAL FORMULATION OF RITU
Sponsors
Dr SUJAY KHANDPUR
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with predominant oral Pemphigus vulgaris (defined as oral involvement with cutaneous involvement less than 1%) or pure oral mucosal involvement diagnosed on basis of clinical features and ELISA for desmoglein 3 antibody with or without positive tzanck smear and mucosal biopsy 2. Patients in age group of 18-72 years. 3. Patients giving consent for participating in study and obtaining mucosal biopsies.
Exclusion criteria
Exclusion criteria: 1. Patients with pemphigus vulgaris with cutaneous involvement more than 1%. 2. Patients unwilling to give consent for study. 3. Patients with history of significant reaction to intravenous rituximab 4. Patients with severe comorbid illness like patients with malignancy, cardiac failure and uncontrolled diabetes mellitus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of proportion of patients in 2 groups achieving remission (defined as more than 90% reepithelialisation of oral erosions) at end of 3 months.Timepoint: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of oral pemphigus vulgaris score between treatment groups at each follow up visit.Timepoint: 3 months;Comparison of total cumulative dose of oral steroids in each group.Timepoint: 3 MONTHS;Proportion of patients achieving remission in each treatment group.Timepoint: 3 MONTHS;Proportion of patients in each treatment group that relapsesTimepoint: 3 MONTHS | — |
Countries
India
Contacts
Public ContactPratik Mohta
AIIMS
Outcome results
None listed