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

Phase 3
Conditions
Health Condition 1: L438- Other lichen planus
Registration Number
CTRI/2024/07/070275
Lead Sponsor
avneet Singh
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
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

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
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
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