Evaluation of Efficacy and Safety of add-on Tofacitinib in Patients With Oral Lichen Planus: A Randomized Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Many of the patients with oral lichen planus (OLP) either fail to achieve complete remission or experience frequent relapses with conventional topical corticosteroid therapy, which is currently the mainstay of treatment. Long-term corticosteroid use is limited by local and systemic adverse effects, and many patients develop steroid resistance or intolerance. To overcome these limitations, combination therapy with agents having complementary mechanisms may improve therapeutic outcomes, reduce steroid requirements, and minimize associated adverse effects. Tofacitinib, a Janus kinase (JAK1/JAK3) inhibitor, modulates the JAK-STAT signaling pathway, thereby reducing inflammatory cytokine production involved in OLP pathogenesis. Preliminary case series and pilot trials have shown promising results with tofacitinib in OLP. However, to date, no randomized controlled trial has evaluated the efficacy and safety of add-on oral tofacitinib with standard topical steroid therapy in OLP. Hence, investigators considered tofacitinib to be a candidate drug for add-on therapy due to its anti-inflammatory and immunomodulatory properties. Adding tofacitinib to ongoing topical triamcinolone therapy may increase the response rate, reduce adverse drug reactions by lowering steroid dose requirements, or achieve a quicker therapeutic effect. Therefore, the present randomized controlled trial has been planned to evaluate the efficacy and safety of oral tofacitinib as an add-on therapy in patients with OLP.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients aged ≥18 of either sex with the clinical diagnosis of oral lichen planus.

• Patients with a PGA score of ≥3 (moderate and severe oral LP).

• Patients who are willing to give informed written consent.

Locations
Other Locations
India
AIIMS, Bhubaneswar
RECRUITING
Bhubaneswar
Contact Information
Primary
Monalisa Jena, MD
pharm_monalisa@aiimsbhubaneswar.edu.in
9438884193
Backup
Biswanath Behera, MD
Dermat_biswanath@aiimsbhubaneswar.edu.in
7978351200
Time Frame
Start Date: 2025-10-10
Estimated Completion Date: 2027-06-01
Participants
Target number of participants: 60
Treatments
Experimental: Test: Capsule Tofacitinib + Triamcinolone ointment
Patients in the test group will get Tofacitinib 5mg twice daily as an add on to topical triamcinolone ointment
Active_comparator: Control: Placebo capsules + Triamcinolone ointment
Patients in the control group will get similar looking capsules containing placebo in addition to triamcinolone ointment
Related Therapeutic Areas
Sponsors
Leads: All India Institute of Medical Sciences, Bhubaneswar

This content was sourced from clinicaltrials.gov