Health Condition 1: L100- Pemphigus vulgaris
Conditions
Interventions
Intervention1: Topical rituximab: Topical rituximab encapsulated in nanogel formulation applied topically on recalcitrant oral erosions of pemphigus vulgaris. Patients will apply 15 drops (amounting t
Sponsors
AIIMS, New Delhi M.D Thesis Grant
Eligibility
Inclusion criteria
Inclusion criteria: 1.Pemphigus vulgaris previously diagnosed based on clinical and histological features, with refractory oral mucosal lesions or remnant lesions defined as failure of established lesions to heal despite adequate treatment for 6 months, which includes tapering schedule of prednisolone and topical steroid, with any of the following agents a.Cyclophosphamide 50mg once a day b.Azathioprine 50 mg twice a day c.Methotrexate 15-20 mg/week d.Mycophenolate mofetil 2 gm/day e.Rituximab- RA or lymphoma protocol 2.Oral erosions that are present at sites accessible to topical and intralesional rituximab 3.No new mucosal or cutaneous lesions for at least 12 weeks. 4.Patients more than or equal to 18 years of age
Exclusion criteria
Exclusion criteria: 1.Patients with cutaneous lesions of PV; with active disease, which is defined by continuing extension of old or development of new lesions in the preceding 12 weeks with adequate treatment 2.Patients less than 18 years of age 3.Pregnant and lactating women 4.Presence of other causes of non-healing oral PV erosions such as trauma due to jagged teeth etc. 5.Patients developing new oral or cutaneous lesions of pemphigus vulgaris during the intervention will be excluded from the study and they will be treated adequately as per the standard protocol for pemphigus vulgaris.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of change in size (area in millimetres square) of the oral erosions between topical rituximab encapsulated in nanoparticle gel and intralesional rituximab in recalcitrant oral PV, measured by using the image J software from baseline at each follow up visitTimepoint: Baseline, 2, 4, 8 and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Comparison of change in Investigator Global Assessment (IGA) scores between the two modalities from baseline at each follow up visitTimepoint: Baseline, 2, 4, 8 and 12 weeks;2. Comparison of change in Patient Global Assessment (PGA) scores between the two modalities from baseline at each follow up visitTimepoint: Baseline, 2, 4, 8 and 12 weeks;3. Comparison of change in Oral Health Impact Profile-14 (OHIP -14) score between the two modalities from baseline at each follow up visitTimepoint: Baseline, 2, 4, 8 and 12 weeks;4. Comparison of change in Oral pemphigus score (including subjective and objective severity) using Saraswat score for oral PV between the two modalities from baseline at each follow up visitTimepoint: Baseline, 2, 4, 8 and 12 weeks;5. Comparison of change in serum CD19 cell count using flow cytometry from baseline at at the end of treatment between the two modalities.Timepoint: Baseline and end of treatment;6. Comparison of change in salivary anti-Dsg3 antibody titres from baseline at the end of treatment between the two modalities.Timepoint: Baseline and end of treatment;7. Comparison of side-effects between the two modalities.Timepoint: During the entire duration of study | — |
Countries
India
Contacts
Public ContactDr Suyash Pawar
Outcome results
None listed