To evaluate the adjuvant potential of methotrexate in mucosal/ limited mucocutaneous pemphigus vulgaris

Phase 2

• Conditions: Health Condition 1: null- mucosal or limited mucocutaneous pemphigus vulgaris (less than 5% BSA)Health Condition 2: L100- Pemphigus vulgaris

• Registration Number: CTRI/2018/07/015002
• Lead Sponsor: PGIMER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified