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

NCT07131813 | Recruiting Phase 4

• 1 other identifier: IEC/AIIMSBBSR/PGThesis/2025/46
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oral Lichen Planus

Keywords

Tofacitinib; Oral Lichen Planus; Randomized Controlled Trial; Placebo; IL 6

Outcome Measures

Primary Outcomes (1)

• Change in oral mucosal disease severity score from baseline

  The change in oral mucosal disease severity score (maximum 106) will be evaluated using oral mucosal disease severity score questionnaire. Each item of the questionnaire yields a score of 0 to 106. A higher score depicts severe disease.

  4 weeks and12 weeks

Secondary Outcomes (5)

• Pain by Pain Visual Analogue Scale (VAS) score

  4 weeks and12 weeks

• Severity by Physician global assessment of disease (PGA) Score

  4 weeks and 12 weeks

• Quality of life by using oral health-related quality of life score (ORAL HEALTH IMPACT PROFILE - 14 )

  4 weeks and 12 weeks

• serum IL 6 level

  12 weeks

• Incidence of treatment-emergent adverse events of both test and control group

  12 weeks

Study Arms (2)

Test: Capsule Tofacitinib + Triamcinolone ointment

EXPERIMENTAL

Patients in the test group will get Tofacitinib 5mg twice daily as an add on to topical triamcinolone ointment

Drug: Tofacitinib 5 mg BID and Triamcinolone ointment

Control: Placebo capsules + Triamcinolone ointment

ACTIVE COMPARATOR

Patients in the control group will get similar looking capsules containing placebo in addition to triamcinolone ointment

Drug: Placebo and Triamcinolone ointment

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

Test: Capsule Tofacitinib + Triamcinolone ointment

Placebo and Triamcinolone ointment DRUG

Patients in the control group will receive identical looking capsules as placebo with triamcinolone ointment

Control: Placebo capsules + Triamcinolone ointment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Treatment with a systemic corticosteroid within the last 4 weeks.
• Patients on immunosuppressive agents such as azathioprine, cyclosporine, and others within one month of recruitment.
• Patients with a clinical history and any lesion distribution suspicious of a lichenoid drug eruption, and patients with other skin diseases.
• Past or current history of any malignancy, including moderate to severe dysplasia of the oral mucosa on oral biopsy.
• Severe active infection, including active tuberculosis, hepatitis B, or C infection
• Patients with cytopenia (Hb \<9g/dl, leukocyte count \<4000/mm3, platelet count \<100,000/mm3)
• The patient with a history of alcohol abuse.
• Decreased liver or renal function (creatinine \> 2.0mg/dl, total bilirubin \> 2.5 mg/dl).
• Severe acute infection, uncontrolled diabetes mellitus, congenital or acquired immunodeficiency, severe cardiac disease (NYHA grade IV), MI in the last four weeks, severe schizophrenia, or depression.
• Patient with a history of hypersensitivity to topical Triamcinolone or Tofacitinib.
• Pregnancy and lactation, women of childbearing age without effective contraception.

Sponsors & Collaborators

• All India Institute of Medical Sciences, Bhubaneswar: lead

Study Sites (1)

AIIMS, Bhubaneswar

Bhubaneswar, Odisha, 751019, India

RECRUITING

Related Publications (6)

• Sandhu S, Klein BA, Al-Hadlaq M, Chirravur P, Bajonaid A, Xu Y, Intini R, Hussein M, Vacharotayangul P, Sroussi H, Treister N, Sonis S. Oral lichen planus: comparative efficacy and treatment costs-a systematic review. BMC Oral Health. 2022 May 6;22(1):161. doi: 10.1186/s12903-022-02168-4.

  PMID: 35524296 RESULT

• Kulkarni S, Durham H, Glover L, Ather O, Phillips V, Nemes S, Cousens L, Blomgran P, Ambery P. Metabolic adverse events associated with systemic corticosteroid therapy-a systematic review and meta-analysis. BMJ Open. 2022 Dec 22;12(12):e061476. doi: 10.1136/bmjopen-2022-061476.

  PMID: 36549729 RESULT

• Rotaru D, Chisnoiu R, Picos AM, Picos A, Chisnoiu A. Treatment trends in oral lichen planus and oral lichenoid lesions (Review). Exp Ther Med. 2020 Dec;20(6):198. doi: 10.3892/etm.2020.9328. Epub 2020 Oct 14.

  PMID: 33123228 RESULT

• Qing M, Yang D, Shang Q, Peng J, Deng J, Lu J, Li J, Dan H, Zhou Y, Xu H, Chen Q. CD8+ tissue-resident memory T cells induce oral lichen planus erosion via cytokine network. Elife. 2023 Aug 9;12:e83981. doi: 10.7554/eLife.83981.

  PMID: 37555396 RESULT

• Alrashdan MS, Cirillo N, McCullough M. Oral lichen planus: a literature review and update. Arch Dermatol Res. 2016 Oct;308(8):539-51. doi: 10.1007/s00403-016-1667-2. Epub 2016 Jun 27.

  PMID: 27349424 RESULT

• Katta R. Lichen planus. Am Fam Physician. 2000 Jun 1;61(11):3319-24, 3327-8.

  PMID: 10865927 RESULT

MeSH Terms

Conditions

Lichen Planus, Oral

Interventions

tofacitinib; BID protein, human

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Rituparna Maiti, MD

  Professor

  STUDY CHAIR

Central Study Contacts

Monalisa Jena, MD

CONTACT

9438884193; pharm_monalisa@aiimsbhubaneswar.edu.in

Biswanath Behera, MD

CONTACT

7978351200; Dermat_biswanath@aiimsbhubaneswar.edu.in

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The recruited patients were randomized into two treatment groups using block randomization (block size 6) with computer-generated random codes, maintaining an allocation ratio 1:1. Random allocation codes will be created by an investigator who does not participate in patient recruitment. The Sequentially Numbered, Opaque, Sealed Envelope (SNOSE) method will be employed to ensure allocation concealment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Additional Professor

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: August 20, 2025
• Study Start: October 10, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)