Oral Lichen PlanusPhase 4NCT06260904
Efficacy and Safety of add-on Apremilast Versus add-on Methotrexate in Patients With Oral Lichen Planus
A Phase 4 study testing Prednisolone, Apremilast and Methotrexate in people with Oral Lichen Planus, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.
Trial summary
Lichen planus is an inflammatory disorder of unknown aetiology affecting the stratified squamous epithelia, with an estimated global prevalence of 0.22 to 0.5 %. Oral mucosa (Oral Lichen Planus; OLP) is the most commonly affected region. Corticosteroids are the primary treatment of choice. 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?
- Prednisolone, Apremilast and Methotrexate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteIndia
- Study dates
- 26 Jan 2024to 30 Oct 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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).
- Patient not responding to topical or intralesional corticosteroid.
- Patients who are willing to give informed written consent.
Who cannot join
- Treatment with a systemic corticosteroid within the last 4 weeks.
- Patients on any immunosuppressive agents such as azathioprine, cyclosporine and others within one month of recruitment.
- Patients with 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
- Patient with 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, untreated glaucoma, congenital or acquired immunodeficiency, active gastroduodenal ulcer, severe osteoporosis, severe cardiac disease (NYHA grade IV), MI in the last four weeks, severe schizophrenia or depression.
- Patient with a history of hypersensitivity to Methotrexate or Apremilast.
- Pregnancy and lactation, women of childbearing age without effective contraception.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of add-on Apremilast Versus add-on Methotrexate in Patients With Oral Lichen Planus: A Randomized Controlled Trial
Lichen planus is an inflammatory disorder of unknown aetiology affecting the stratified squamous epithelia, with an estimated global prevalence of 0.22 to 0.5 %. Oral mucosa (Oral Lichen Planus; OLP) is the most commonly affected region. Corticosteroids are the primary treatment of choice. A prolonged treatment with steroids is required for clinical improvement, which increases the chances of long-term adverse effects. So, there is a need for newer, effective treatment modalities, such as retinoids, methotrexate, Janus kinase inhibitors, PDE4 inhibitors, etc.
Of these, methotrexate is a dihydrofolate reductase inhibitor that inhibits the replication and function of T and B lymphocytes. It has shown a good response to OLP (around 83%) in a study by Lajevardi et al. and can be considered a treatment option in patients with moderate to severe OLP. Apremilast is a drug with a novel immunomodulatory mechanism of action. It inhibits phosphodiesterase type IV, which increases levels of cyclic adenosine monophosphate (cAMP), thus activating protein kinase A and inhibiting various inflammatory mediators. Based on a pilot study by Paul et al., apremilast is associated with clinical improvement in lichen planus.
Among the various treatment options, there is a lack of head-on trials. Methotrexate is an immunosuppressant with various systemic adverse effects and requires close monitoring. Whereas apremilast is a non-immunosuppressive drug with a better safety profile, it does not show such adverse effects. These drugs can be used as an add-on to low-dose steroids in view of reducing the adverse effects associated with steroid therapy. To the best of our knowledge, there is no randomized controlled trial comparing these two drugs to date. Hence, the present study has been planned to evaluate the safety and efficacy of methotrexate versus apremilast as an add-on to the standard steroid therapy in OLP patients.
- Conditions
- Oral Lichen Planus
- Being tested
- Prednisolone, Apremilast, Methotrexate
- Keywords
- Lichen planus, Oral lichen planus, Prednisolone, Methotrexate, Apremilast, IL 6, VAS, PGA
- Medical subject headings
- Lichen Planus, Oral, Lichen Planus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoloneDrug
prednisolone 0.75mg/kg/day (a maximum dose of 30mg at baseline) orally
ApremilastDrug
Apremilast 30 mg twice daily orally
MethotrexateDrug
Methotrexate 15 mg weekly orally
| Study group | Role | What they receive |
|---|---|---|
| Prednisolone and Methotrexate (Control Arm) | Active comparator | prednisolone 0.75mg/kg/day (a maximum dose of 30mg at baseline) and Methotrexate 15 mg weekly for 12 weeks. Receives: Drug: Prednisolone; Drug: Methotrexate |
| Prednisolone and Apremilast (Test Arm) | Experimental | prednisolone 0.75mg/kg/day (a maximum dose of 30mg at baseline) and Apremilast 30 mg twice daily for 12 weeks. Receives: Drug: Prednisolone; Drug: Apremilast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain by Visual Analogue Scale (VAS) score
Change in Visual Analogue Scale (VAS) score after treatment with prednisolone and methotraxate Vs Prednisolone and Apremilast at baseline, 8 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: 8 weeks and 12 weeks
Secondary outcomes (5)
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 prednisolone and methotraxate Vs Prednisolone and Apremilast at baseline, 8 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: 8 weeks and 12 weeks
Severity and pain by oral mucosal disease severity score
the change in oral mucosal disease severity score (maximum 106) after treatment with prednisolone and methotraxate Vs Prednisolone and Apremilast at baseline, 8 weeks and 12 weeks.
Total score = Site score + Activity score + pain Score (Maximum 106) higher scores indicating greater disease activity
Measured: 8 weeks and 12 weeks
serum IL 6 level
Change in serum IL 6 after treatment with prednisolone and methotraxate Vs Prednisolone and Apremilast he levels of salivary and serum IL-6 were significantly higher among patients with OLP than among healthy control participants
Measured: 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 8 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 and lower scores indicate better OHRQol
Measured: 8 weeks and 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 prednisolone, methotrexate and apremilast.
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 posted15 Feb 2024
- Study start26 Jan 2024
- Primary completion30 Oct 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
- Model description
- randomized, add-on, active-controlled, open-label, parallel-design clinical trial
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
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
- Debasish Hota, MD, DM, Study director, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06260904
- Sponsor's protocol ID
- AIIMS BBSR/PGThesis/23-24/112
- Status last verified
- Nov 2025
- First submitted
- 25 Jan 2024
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gorouhi F, Davari P, Fazel N. Cutaneous and mucosal lichen planus: a comprehensive review of clinical subtypes, risk factors, diagnosis, and prognosis. ScientificWorldJournal. 2014 Jan 30;2014:742826. doi: 10.1155/2014/742826. eCollection 2014.
PubMed 24672362Farhi D, Dupin N. Pathophysiology, etiologic factors, and clinical management of oral lichen planus, part I: facts and controversies. Clin Dermatol. 2010 Jan-Feb;28(1):100-8. doi: 10.1016/j.clindermatol.2009.03.004.
PubMed 20082959Solimani F, Forchhammer S, Schloegl A, Ghoreschi K, Meier K. Lichen planus - a clinical guide. J Dtsch Dermatol Ges. 2021 Jun;19(6):864-882. doi: 10.1111/ddg.14565. Epub 2021 Jun 7.
PubMed 34096678Veneri F, Bardellini E, Amadori F, Conti G, Majorana A. Efficacy of ozonized water for the treatment of erosive oral lichen planus: a randomized controlled study. Med Oral Patol Oral Cir Bucal. 2020 Sep 1;25(5):e675-e682. doi: 10.4317/medoral.23693.
PubMed 32683383Le Cleach L, Chosidow O. Clinical practice. Lichen planus. N Engl J Med. 2012 Feb 23;366(8):723-32. doi: 10.1056/NEJMcp1103641. No abstract available.
PubMed 22356325Mohan RPS, Gupta A, Kamarthi N, Malik S, Goel S, Gupta S. Incidence of Oral Lichen Planus in Perimenopausal Women: A Cross-sectional Study in Western Uttar Pradesh Population. J Midlife Health. 2017 Apr-Jun;8(2):70-74. doi: 10.4103/jmh.JMH_34_17.
PubMed 28706407Kanwar AJ, De D. Methotrexate for treatment of lichen planus: old drug, new indication. J Eur Acad Dermatol Venereol. 2013 Mar;27(3):e410-3. doi: 10.1111/j.1468-3083.2012.04654.x. Epub 2012 Jul 24.
PubMed 22827806Lajevardi V, Ghodsi SZ, Hallaji Z, Shafiei Z, Aghazadeh N, Akbari Z. Treatment of erosive oral lichen planus with methotrexate. J Dtsch Dermatol Ges. 2016 Mar;14(3):286-93. doi: 10.1111/ddg.12636.
PubMed 26972194Chauhan P, De D, Handa S, Narang T, Saikia UN. A prospective observational study to compare efficacy of topical triamcinolone acetonide 0.1% oral paste, oral methotrexate, and a combination of topical triamcinolone acetonide 0.1% and oral methotrexate in moderate to severe oral lichen planus. Dermatol Ther. 2018 Jan;31(1). doi: 10.1111/dth.12563. Epub 2017 Nov 10.
PubMed 29124831Papp K, Reich K, Leonardi CL, Kircik L, Chimenti S, Langley RG, Hu C, Stevens RM, Day RM, Gordon KB, Korman NJ, Griffiths CE. Apremilast, an oral phosphodiesterase 4 (PDE4) inhibitor, in patients with moderate to severe plaque psoriasis: Results of a phase III, randomized, controlled trial (Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis [ESTEEM] 1). J Am Acad Dermatol. 2015 Jul;73(1):37-49. doi: 10.1016/j.jaad.2015.03.049.
PubMed 26089047
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of add-on Apremilast Versus add-on Methotrexate in Patients With Oral Lichen Planus: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06260904
- Acronym / sponsor ID
- AIIMS BBSR/PGThesis/23-24/112
- Conditions
- Oral Lichen Planus
- Keywords
- Lichen planus, Oral lichen planus, Prednisolone, Methotrexate, Apremilast, IL 6, VAS, PGA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- All India Institute of Medical Sciences, BhubaneswarUniversity, hospital or other
- Study start
- 26 Jan 2024 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 15 Feb 2024 (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.
Lichen planus is an inflammatory disorder of unknown aetiology affecting the stratified squamous epithelia, with an estimated global prevalence of 0.22 to 0.5 %. Oral mucosa (Oral Lichen Planus; OLP) is the most commonly affected region. Corticosteroids are the primary treatment of choice. A prolonged treatment with steroids is required for clinical improvement, which increases the chances of long-term adverse effects. So, there is a need for newer, effective treatment modalities, such as retinoids, methotrexate, Janus kinase inhibitors, PDE4 inhibitors, etc.
Of these, methotrexate is a dihydrofolate reductase inhibitor that inhibits the replication and function of T and B lymphocytes. It has shown a good response to OLP (around 83%) in a study by Lajevardi et al. and can be considered a treatment option in patients with moderate to severe OLP. Apremilast is a drug with a novel immunomodulatory mechanism of action. It inhibits phosphodiesterase type IV, which increases levels of cyclic adenosine monophosphate (cAMP), thus activating protein kinase A and inhibiting various inflammatory mediators. Based on a pilot study by Paul et al., apremilast is associated with clinical improvement in lichen planus.
Among the various treatment options, there is a lack of head-on trials. Methotrexate is an immunosuppressant with various systemic adverse effects and requires close monitoring. Whereas apremilast is a non-immunosuppressive drug with a better safety profile, it does not show such adverse effects. These drugs can be used as an add-on to low-dose steroids in view of reducing the adverse effects associated with steroid therapy. To the best of our knowledge, there is no randomized controlled trial comparing these two drugs to date. Hence, the present study has been planned to evaluate the safety and efficacy of methotrexate versus apremilast as an add-on to the standard steroid therapy in OLP patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized, add-on, active-controlled, open-label, parallel-design clinical trial
| Arm | Type | Receives |
|---|---|---|
| Prednisolone and Methotrexate (Control Arm) | Active comparator | Drug: Prednisolone, Drug: Methotrexateprednisolone 0.75mg/kg/day (a maximum dose of 30mg at baseline) and Methotrexate 15 mg weekly for 12 weeks. |
| Prednisolone and Apremilast (Test Arm) | Experimental | Drug: Prednisolone, Drug: Apremilastprednisolone 0.75mg/kg/day (a maximum dose of 30mg at baseline) and Apremilast 30 mg twice daily for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 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).
- Patient not responding to topical or intralesional corticosteroid.
- 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 any immunosuppressive agents such as azathioprine, cyclosporine and others within one month of recruitment.
- Patients with 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 |
|---|---|---|
| Prednisoloneprednisolone 0.75mg/kg/day (a maximum dose of 30mg at baseline) orally | Drug | Prednisolone and Apremilast (Test Arm), Prednisolone and Methotrexate (Control Arm) |
| ApremilastApremilast 30 mg twice daily orally | Drug | Prednisolone and Apremilast (Test Arm) |
| MethotrexateMethotrexate 15 mg weekly orally | Drug | Prednisolone and Methotrexate (Control Arm) |
Primary outcome
Pain by Visual Analogue Scale (VAS) score
Time frame: 8 weeks and 12 weeks
Change in Visual Analogue Scale (VAS) score after treatment with prednisolone and methotraxate Vs Prednisolone and Apremilast at baseline, 8 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
5 secondary outcomes
Severity by Physician global assessment of disease (PGA) score
Time frame: 8 weeks and 12 weeks
Severity and pain by oral mucosal disease severity score
Time frame: 8 weeks and 12 weeks
serum IL 6 level
Time frame: 12 weeks
Quality of life by using oral health-related quality of life score (ORAL HEALTH IMPACT PROFILE - 14 )
Time frame: 8 weeks and 12 weeks
Incidence of treatment-emergent adverse events of both test and control group
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Background: PubMed 24672362Gorouhi F, Davari P, Fazel N. Cutaneous and mucosal lichen planus: a comprehensive review of clinical subtypes, risk factors, diagnosis, and prognosis. ScientificWorldJournal. 2014 Jan 30;2014:742826. doi: 10.1155/2014/742826. eCollection 2014.
- Background: PubMed 20082959Farhi D, Dupin N. Pathophysiology, etiologic factors, and clinical management of oral lichen planus, part I: facts and controversies. Clin Dermatol. 2010 Jan-Feb;28(1):100-8. doi: 10.1016/j.clindermatol.2009.03.004.
- Background: PubMed 34096678Solimani F, Forchhammer S, Schloegl A, Ghoreschi K, Meier K. Lichen planus - a clinical guide. J Dtsch Dermatol Ges. 2021 Jun;19(6):864-882. doi: 10.1111/ddg.14565. Epub 2021 Jun 7.
- Background: PubMed 32683383Veneri F, Bardellini E, Amadori F, Conti G, Majorana A. Efficacy of ozonized water for the treatment of erosive oral lichen planus: a randomized controlled study. Med Oral Patol Oral Cir Bucal. 2020 Sep 1;25(5):e675-e682. doi: 10.4317/medoral.23693.
- Background: PubMed 22356325Le Cleach L, Chosidow O. Clinical practice. Lichen planus. N Engl J Med. 2012 Feb 23;366(8):723-32. doi: 10.1056/NEJMcp1103641. No abstract available.
- Background: PubMed 28706407Mohan RPS, Gupta A, Kamarthi N, Malik S, Goel S, Gupta S. Incidence of Oral Lichen Planus in Perimenopausal Women: A Cross-sectional Study in Western Uttar Pradesh Population. J Midlife Health. 2017 Apr-Jun;8(2):70-74. doi: 10.4103/jmh.JMH_34_17.
- Background: PubMed 22827806Kanwar AJ, De D. Methotrexate for treatment of lichen planus: old drug, new indication. J Eur Acad Dermatol Venereol. 2013 Mar;27(3):e410-3. doi: 10.1111/j.1468-3083.2012.04654.x. Epub 2012 Jul 24.
- Background: PubMed 26972194Lajevardi V, Ghodsi SZ, Hallaji Z, Shafiei Z, Aghazadeh N, Akbari Z. Treatment of erosive oral lichen planus with methotrexate. J Dtsch Dermatol Ges. 2016 Mar;14(3):286-93. doi: 10.1111/ddg.12636.
- Background: PubMed 29124831Chauhan P, De D, Handa S, Narang T, Saikia UN. A prospective observational study to compare efficacy of topical triamcinolone acetonide 0.1% oral paste, oral methotrexate, and a combination of topical triamcinolone acetonide 0.1% and oral methotrexate in moderate to severe oral lichen planus. Dermatol Ther. 2018 Jan;31(1). doi: 10.1111/dth.12563. Epub 2017 Nov 10.
- Background: PubMed 26089047Papp K, Reich K, Leonardi CL, Kircik L, Chimenti S, Langley RG, Hu C, Stevens RM, Day RM, Gordon KB, Korman NJ, Griffiths CE. Apremilast, an oral phosphodiesterase 4 (PDE4) inhibitor, in patients with moderate to severe plaque psoriasis: Results of a phase III, randomized, controlled trial (Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis [ESTEEM] 1). J Am Acad Dermatol. 2015 Jul;73(1):37-49. doi: 10.1016/j.jaad.2015.03.049.
- Individual participant dataSharing planned: No
Related trials for Oral Lichen Planus
RecruitingObservational study
Salivary IL-8 and Serum IL-6 as Biomarkers for Oral Potentially Malignant Disorders in Smokers and Never-Smokers
Oral Potentially Malignant Disorders, Oral Lichen Planus
Not yet recruiting
Curcumin-mediated Photodynamic Therapy Versus Photobiomodulation in the Treatment of Oral Erosive Lichen Planus
Oral Lichen Planus
Not yet recruiting
Adherence to Topical and Systemic Medications Among Symptomatic Oral Lichen Planus Patients: A Pilot Randomized Clinical Trial
Degree of Adherence of Symptomatic OLP Patients to Their Medications
Active, not recruitingPhase 4
Low Level Laser Therapy With Injectable Platelet Rich Fibrin in Management of Oral Lichen Planus
Oral Lichen Planus
Active, not recruiting
Widefield Fluorescence and Reflectance Imaging Systems and Oral Tissue Samples in Monitoring Participants at Risk for Developing Oral Cancer
Erythroplakia, Fanconi Anemia
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. This study is not recruiting at the moment.
Debasish Hota, MD, DM study director
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 Prednisolone, Apremilast and Methotrexate 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 4 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: finished, as of the sponsor's last update on 3 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain by Visual Analogue Scale (VAS) score (time frame: 8 weeks and 12 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 NCT06260904, which also lists 10 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 3 Dec 2025.