Effectiveness and safety of oral steroid compared to tofacitinib in cases of lichen planus involving skin or oral cavity.

Effectiveness and safety of oral prednisolone vs tofacitinib in management of oral and mucocutaneous lichen planus: Investigator blind, active-controlled, randomized clinical trial. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/07/055368

Enrollment

Registered

2023-07-19

Start date

Unknown

Completion date

Unknown

Last updated

2023-07-25

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

Conditions

Health Condition 1: L43- Lichen planus

Interventions

Intervention1: Tofacitinib: At the baseline visit tofacitinib(5mg twice/day) would be given as regimen. At the 2nd week patient would be inquired about the side-effects of the drug, effectiveness para

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
To assess the Lichen Planus Activity & Damage Index (LiPADI). The adverse event complained by the patients b. Adverse event noted by the investigator c. Biochemical, Hematological examination findingsTimepoint: 0 week baseline visit 2nd week follow up visit 6th week follow up visit 12th week follow up visit	—

Secondary

Measure	Time frame
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 At the end of 12th week the quality of life will be again checked	—

Countries

India

Contacts

Public ContactRhitam Ghosal

College of Medicine and Sagore Dutta Hospital

drdasnilay@gmail.com9433394148

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026