Effectiveness and safety of oral steroid compared to tofacitinib in cases of lichen planus involving skin or oral cavity.
- Conditions
- Health Condition 1: L43- Lichen planus
- Registration Number
- CTRI/2023/07/055368
- Lead Sponsor
- College of Medicine and Sagore Dutta Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.All clinically and histologically proven cases of oral lichen planus (OLP) with or without dermatological manifestations
2.Patients suffering from lichen planus who have not responded to topical therapy and conventional treatment.
3.Recurring cases of lichen planus
4.No use of any systemic therapy in patients suffering from lichen planus in the previous 4 weeks prior to enrolment in the study
5.Patients willing to come for follow up at regular intervals
1.Extremes of age comprising children below the age of 18years and elderly patients above the age of 65 years will be excluded from the study.
2.Pregnant and lactating women
3.Patients with asymptomatic OLP
3.Patients with uncontrolled diabetes mellitus, hypertension
4.Patient under immunosuppressive drugs.
5.Patients with concomitant immune disorders, heart disease, renal failure, malignancy
6.Patients with neurological or psychiatric disorders.
7.Patients who have participated in any clinical trial within the last 3 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the Lichen Planus Activity & Damage Index (LiPADI). <br/ ><br>The adverse event complained by the patients <br/ ><br>b. Adverse event noted by the investigator <br/ ><br>c. Biochemical, Hematological examination findingsTimepoint: 0 week baseline visit <br/ ><br>2nd week follow up visit <br/ ><br>6th week follow up visit <br/ ><br>12th week follow up visit
- Secondary Outcome Measures
Name Time Method To assess the quality of life of the patients through Oral Health Impact Profile-14 (OHIP 14) & Dermatology Life Quality Index ( DLQI )Timepoint: In Baseline visit, quality of life will be monitored <br/ ><br>At the end of 12th week the quality of life will be again checked