Evaluation of Efficacy and Safety of add-on Tofacitinib in Patients With Oral Lichen Planus

Sponsor
All India Institute of Medical Sciences, Bhubaneswar
Study ID
NCT07131813
Phase
PHASE4
Status
Recruiting
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Conditions

  • Oral Lichen Planus

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tofacitinib 5 mg BID and Triamcinolone ointment — DRUG
    Patients in the test group will get tofacitinib 5mg capsules twice daily as an add on to triamcinolone ointment
  • Placebo and Triamcinolone ointment — DRUG
    Patients in the control group will receive identical looking capsules as placebo with triamcinolone ointment

Study Details

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.

Key Dates

Start date
Oct 10, 2025
Status verified
Nov 2025
Primary completion
Jan 1, 2027
Completion
Jun 1, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Change in oral mucosal disease severity score from baseline [ Time Frame: 4 weeks and12 weeks ]

Central Contacts