Comparing efficacy of two different drugs in management of oral lichen planus

Efficacy and safety of oral methotrexate vs oral tofacitinib in management of oral lichen planus A prospective randomised study - Nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/07/070275

Enrollment

Registered

2024-07-09

Start date

Unknown

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L438- Other lichen planus

Interventions

Intervention1: Oral Methotrexate according to body weight: Patients will receive treatment with oral methotrexate, dosed according to standard clinical guidelines ( first test dose of 2.5 mg is given,

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients who are diagnosed case of oral lichen planus with or without skin lesions . 2. Both sexes - Male and Female. 3. Age- More than 18 years and less than 60 years

Exclusion criteria

Exclusion criteria: 1. Age less than 18 years or more than 60 years. 2. Pregnancy, those female patients who are planning for pregnancy in next one month and lactation. 3. Patients unwilling to give consent to be part of trial. 4. Patients with active or latent TB. 5. Patients with anemia, liver disease, kidney disease, GI disease ( diverticulitis, perforation, ulcers ), respiratory disease ( ILD, COPD, pulmonary edema ) 6. Patients with malignancies or lymphoproliferative disorders. 7. Patients on potent immunosuppressants, biological DMARDS, H/O organ transplant. 8. Patients with deranged lipid profile. 9. H/O recent live vaccination. 10. Family history of melanoma/non melanoma skin disorders. 11. Alcohol intake, tobacco and smoking. 12. Obesity. 13. H/o any thromboembolic event, cardiovascular disease, stroke.

Design outcomes

Primary

Measure	Time frame
Primary outcome include evaluation and assessment of therapeutic response of methotrexate and tofacitinib in oral lichen planus according to Thongprasom score.Timepoint: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks, Follow up period of 3 months	—

Secondary

Measure	Time frame
Secondary outcome include safety profile and tolerability of oral methotrexate and oral tofacitinib in the treatment of oral lichen planus.Timepoint: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks, follow up period of 3 months	—

Countries

India

Contacts

Public ContactNavneet Singh

Shri Bhusaheb Hire Government Medical College

drchetanrajput@yahoo.com8888487808

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 9, 2026