Oral Lichen PlanusPhase 4NCT07131813
Evaluation of Efficacy and Safety of add-on Tofacitinib in Patients With Oral Lichen Planus
A Phase 4 study testing Tofacitinib 5 mg BID and Triamcinolone ointment in people with Oral Lichen Planus, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Lichen Planus
- What is being tested?
- Tofacitinib 5 mg BID and Triamcinolone ointment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 10 Oct 2025to 1 Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
AIIMS, Bhubaneswar
Bhubaneswar, Odisha, 751019
Monalisa Jena, MD, 9438884193, pharm_monalisa@aiimsbhubaneswar.edu.in
Ajaya Sahoo, MD
About this study
Official title: Evaluation of Efficacy and Safety of add-on Tofacitinib in Patients With Oral Lichen Planus: A Randomized Clinical Trial
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.
Read the detailed description
Lichen planus (LP) is a chronic, mucocutaneous inflammatory disorder that manifests as violaceous, polygonal, flat-topped papules and plaques, usually affecting the skin, oral mucosa, genital mucosa, and nails. Oral Lichen Planus (OLP) is the most persistent and symptomatic of its many forms, frequently impairing basic functions like eating, speaking, and swallowing. Oral Lichen Planus is an immune-mediated condition characterized by symmetrical, bilateral lesions most frequently seen on the tongue, gingiva, and buccal mucosa. Although the exact etiopathogenesis is unknown, antigen-specific T-cell-mediated cytotoxicity is thought to be a contributing factor. Early diagnosis, therapy, and follow-up are necessary because the disease has a relapsing-remitting course and, in a small percentage of patients, can potentially change into malignancies, particularly in its erosive and atrophic forms.
Oral Lichen Planus can be managed using a variety of treatment approaches, depending on its severity and clinical manifestation. Asymptomatic lesions can be controlled with observation and proper oral hygiene techniques without needing medication. Topical anesthetics and anti-inflammatory drugs can be used to treat mild cases of OLP. Because of their strong anti-inflammatory properties, topical corticosteroids continue to be the cornerstone of treatment for more severe atrophic or erosive forms. However, many patients have numerous relapses and are unable to attain complete remission with monotherapy. Adverse effects, such as oral candidiasis, mucosal thinning, and altered taste perception, are also linked to long-term usage of corticosteroids.
There is no definitive and proven treatment for OLP, despite the wide range of available options, including systemic immunosuppressants like cyclosporine and azathioprine and more recent techniques like laser therapy and photodynamic therapy. Furthermore, there aren't many well-designed, randomized controlled trials that direct standardized care. Therefore, the majority of therapy alternatives are empirical. Patients resistant to corticosteroids present a therapeutic dilemma, necessitating the exploration of newer, targeted options. Janus kinase (JAK) inhibitors, especially tofacitinib, have recently shown promise in treating immune-mediated dermatological disorders, including LP. Tofacitinib suppresses the generation of inflammatory cytokines associated with OLP pathogenesis by modulating the JAK-STAT signaling pathway through the selective inhibition of JAK1 and JAK3. According to preliminary case series and pilot trials, tofacitinib, when applied topically or systemically, can significantly improve erosive OLP, particularly in steroid-refractory cases.
However, to the best of investigator's knowledge, no randomized controlled trials have systematically evaluated the add-on effect of tofacitinib to standard topical steroid therapy in OLP patients. This represents a significant gap in current literature, particularly in defining the role of combination therapies that might offer enhanced efficacy, reduce cumulative steroid doses, and mitigate steroid-related adverse effects. Therefore, this study aims to evaluate the efficacy and safety of tofacitinib as an add-on to topical triamcinolone therapy in patients with oral lichen planus. This trial seeks to provide robust evidence that could potentially redefine treatment paradigms for OLP.
- Conditions
- Oral Lichen Planus
- Being tested
- Tofacitinib 5 mg BID and Triamcinolone ointment, Placebo and Triamcinolone ointment
- Keywords
- Tofacitinib, Oral Lichen Planus, Randomized Controlled Trial, Placebo, IL 6
- Medical subject headings
- Lichen Planus, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tofacitinib 5 mg BID and Triamcinolone ointmentDrug
Patients in the test group will get tofacitinib 5mg capsules twice daily as an add on to triamcinolone ointment
Placebo and Triamcinolone ointmentDrug
Patients in the control group will receive identical looking capsules as placebo with triamcinolone ointment
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Placebo and Triamcinolone ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks and12 weeks
Secondary outcomes (5)
Pain by Pain Visual Analogue Scale (VAS) score
Change in Pain Visual Analogue Scale (VAS) score after treatment with triamcinolone ointment and capsule tofacitinib vs. triamcinolone ointment and capsule placebo at baseline, 4 weeks, and 12 weeks. The VAS consists of a 10 cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Interpretation of the scores:0 = No pain, 2= Mild, 4 = Nagging, 6 = Miserable, 8 = intense, 10 = worst
Measured: 4 weeks and12 weeks
Severity by Physician global assessment of disease (PGA) Score
Compare the proportion of patients achieving a reduction of Physician Global Assessment of Disease (PGA) score of 0 or a 2-grade reduction (minimum initial PGA 3) after treatment with triamcinolone ointment and capsule tofacitinib vs. triamcinolone ointment and capsule placebo at baseline, 4 weeks, and 12 weeks by using a 6-point disease severity scoring system. (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe).
Measured: 4 weeks and 12 weeks
Quality of life by using oral health-related quality of life score (ORAL HEALTH IMPACT PROFILE - 14 )
Change in the oral health-related quality of life from baseline after 4 and 12 weeks. designed to assess patients' perception of the impact of oral disorders on their quality of life (QoL). The OHIP-14 scores can range from 0 to 56 and are calculated by summing the ordinal values for the 14 items. The domain scores can range from 0 to 8. Higher OHIP-14 scores indicate worse OHRQoL, and lower scores indicate better OHRQol
Measured: 4 weeks and 12 weeks
serum IL 6 level
Change in serum IL-6 after treatment with ointment triamcinolone and capsule tofacitinib vs. ointment triamcinolone and capsule placebo. The levels of salivary and serum IL-6 were significantly higher among patients with OLP than among healthy control participants
Measured: 12 weeks
Incidence of treatment-emergent adverse events of both test and control group
treatment-emergent adverse events in both the groups The adverse events in the patients are to be assessed by non-directive questioning at the time of the follow-up visit. Patients can access the investigators directly in case of any adverse events and report them. All adverse events irrespective of their previous reported status are to be recorded with details about nature, intensity, duration, measures taken, outcome, and causal relationship to tofacitinib, triamcinolone and placebo.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start10 Oct 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Oral Lichen PlanusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences, Bhubaneswar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Monalisa Jena, M.D., All India Institute of Medical Sciences, Bhubaneswar
- Investigators
- Rituparna Maiti, MD, Study chair, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07131813
- Sponsor's protocol ID
- IEC/AIIMSBBSR/PGThesis/2025/46
- Status last verified
- Nov 2025
- First submitted
- 13 Aug 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35524296Kulkarni 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.
PubMed 36549729Rotaru 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.
PubMed 33123228Qing 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.
PubMed 37555396Alrashdan 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.
PubMed 27349424Katta R. Lichen planus. Am Fam Physician. 2000 Jun 1;61(11):3319-24, 3327-8.
PubMed 10865927
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy and Safety of add-on Tofacitinib in Patients With Oral Lichen Planus: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07131813
- Acronym / sponsor ID
- IEC/AIIMSBBSR/PGThesis/2025/46
- Conditions
- Oral Lichen Planus
- Keywords
- Tofacitinib, Oral Lichen Planus, Randomized Controlled Trial, Placebo, IL 6
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- All India Institute of Medical Sciences, BhubaneswarUniversity, hospital or other
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 20 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Lichen planus (LP) is a chronic, mucocutaneous inflammatory disorder that manifests as violaceous, polygonal, flat-topped papules and plaques, usually affecting the skin, oral mucosa, genital mucosa, and nails. Oral Lichen Planus (OLP) is the most persistent and symptomatic of its many forms, frequently impairing basic functions like eating, speaking, and swallowing. Oral Lichen Planus is an immune-mediated condition characterized by symmetrical, bilateral lesions most frequently seen on the tongue, gingiva, and buccal mucosa. Although the exact etiopathogenesis is unknown, antigen-specific T-cell-mediated cytotoxicity is thought to be a contributing factor. Early diagnosis, therapy, and follow-up are necessary because the disease has a relapsing-remitting course and, in a small percentage of patients, can potentially change into malignancies, particularly in its erosive and atrophic forms.
Oral Lichen Planus can be managed using a variety of treatment approaches, depending on its severity and clinical manifestation. Asymptomatic lesions can be controlled with observation and proper oral hygiene techniques without needing medication. Topical anesthetics and anti-inflammatory drugs can be used to treat mild cases of OLP. Because of their strong anti-inflammatory properties, topical corticosteroids continue to be the cornerstone of treatment for more severe atrophic or erosive forms. However, many patients have numerous relapses and are unable to attain complete remission with monotherapy. Adverse effects, such as oral candidiasis, mucosal thinning, and altered taste perception, are also linked to long-term usage of corticosteroids.
There is no definitive and proven treatment for OLP, despite the wide range of available options, including systemic immunosuppressants like cyclosporine and azathioprine and more recent techniques like laser therapy and photodynamic therapy. Furthermore, there aren't many well-designed, randomized controlled trials that direct standardized care. Therefore, the majority of therapy alternatives are empirical. Patients resistant to corticosteroids present a therapeutic dilemma, necessitating the exploration of newer, targeted options. Janus kinase (JAK) inhibitors, especially tofacitinib, have recently shown promise in treating immune-mediated dermatological disorders, including LP. Tofacitinib suppresses the generation of inflammatory cytokines associated with OLP pathogenesis by modulating the JAK-STAT signaling pathway through the selective inhibition of JAK1 and JAK3. According to preliminary case series and pilot trials, tofacitinib, when applied topically or systemically, can significantly improve erosive OLP, particularly in steroid-refractory cases.
However, to the best of investigator's knowledge, no randomized controlled trials have systematically evaluated the add-on effect of tofacitinib to standard topical steroid therapy in OLP patients. This represents a significant gap in current literature, particularly in defining the role of combination therapies that might offer enhanced efficacy, reduce cumulative steroid doses, and mitigate steroid-related adverse effects. Therefore, this study aims to evaluate the efficacy and safety of tofacitinib as an add-on to topical triamcinolone therapy in patients with oral lichen planus. This trial seeks to provide robust evidence that could potentially redefine treatment paradigms for OLP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test: Capsule Tofacitinib + Triamcinolone ointment | Experimental | Drug: Tofacitinib 5 mg BID and Triamcinolone ointmentPatients in the test group will get Tofacitinib 5mg twice daily as an add on to topical triamcinolone ointment |
| Control: Placebo capsules + Triamcinolone ointment | Active comparator | Drug: Placebo and Triamcinolone ointmentPatients in the control group will get similar looking capsules containing placebo in addition to triamcinolone ointment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tofacitinib 5 mg BID and Triamcinolone ointmentPatients in the test group will get tofacitinib 5mg capsules twice daily as an add on to triamcinolone ointment | Drug | Test: Capsule Tofacitinib + Triamcinolone ointment |
| Placebo and Triamcinolone ointmentPatients in the control group will receive identical looking capsules as placebo with triamcinolone ointment | Drug | Control: Placebo capsules + Triamcinolone ointment |
Primary outcome
Change in oral mucosal disease severity score from baseline
Time frame: 4 weeks and12 weeks
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.
5 secondary outcomes
Pain by Pain Visual Analogue Scale (VAS) score
Time frame: 4 weeks and12 weeks
Severity by Physician global assessment of disease (PGA) Score
Time frame: 4 weeks and 12 weeks
Quality of life by using oral health-related quality of life score (ORAL HEALTH IMPACT PROFILE - 14 )
Time frame: 4 weeks and 12 weeks
serum IL 6 level
Time frame: 12 weeks
Incidence of treatment-emergent adverse events of both test and control group
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Results publication: PubMed 35524296Sandhu 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.
- Results publication: PubMed 36549729Kulkarni 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.
- Results publication: PubMed 33123228Rotaru 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.
- Results publication: PubMed 37555396Qing 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.
- Results publication: PubMed 27349424Alrashdan 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.
- Results publication: PubMed 10865927Katta R. Lichen planus. Am Fam Physician. 2000 Jun 1;61(11):3319-24, 3327-8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rituparna Maiti, MD study chair
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tofacitinib 5 mg BID and Triamcinolone ointment in people with Oral Lichen Planus, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Monalisa Jena, MD (9438884193, pharm_monalisa@aiimsbhubaneswar.edu.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in oral mucosal disease severity score from baseline (time frame: 4 weeks and12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07131813, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.