Health Condition 1: null- mucosal or limited mucocutaneous pemphigus vulgaris (less than 5% BSA) Health Condition 2: L100- Pemphigus vulgaris
Conditions
Interventions
Intervention1: methotrexate & prednisolone: Prednisolone will be prescribed at a dose of 1 mg/kg/day (rounded off to nearest multiple of 5, upto a maximum dosage of 80 mg/day) in a single morning dose
Sponsors
PGIMER
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of pemphigus vulgaris with oral mucosal lesions with no cutaneous involve- ment or limited cutaneous involvement (i.e. less than 5% BSA) 2. Attending the immunobullous disease clinic of the Department of Dermatology for the first time 3. Age more than 18 years. 4. Willing for biweekly follow up for 1 month & monthly follow up visits for atleast 8 months thereafter
Exclusion criteria
Exclusion criteria: 1. Individuals upto 18 years of age 2. Inability to come for follow up till 9 months 3. Pregnant and lactating females 4. Elderly patients aged 70 years or older for practical difficulty in following up or unre- liable patients 5. Significant anaemia, leukopenia or thrombocytopenia 6. Chronic infection or immunosuppressed state (e.g TB, HIV) 7. Heavy alcohol consumption or hepatic impairment 8. Renal insufficiency 9. History suggestive of allergy to methotrexate 10. Planning to start a family in next 12 months or not willing for contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of the total cumulative dose of prednisolone required over 9 months study period Timepoint: Assessment of the total cumulative dose of prednisolone required over 9 months study period | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall remission rateTimepoint: 9 months;Time to remission off treatmentTimepoint: 9 months;Time to remission with minimal treatment Timepoint: 9 months | — |
Countries
India
Contacts
Public ContactDr Khimit Jain
PGIMER, Chandigarh
Outcome results
None listed