Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06260904
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-15
First Post:
2024-01-25
Brief Title:
Efficacy and Safety of add-on Apremilast Versus add-on Methotrexate in Patients With Oral Lichen Planus
Sponsor:
All India Institute of Medical Sciences Bhubaneswar
Organization:
All India Institute of Medical Sciences Bhubaneswar
Study Overview
Official Title:
Efficacy and Safety of add-on Apremilast Versus add-on Methotrexate in Patients With Oral Lichen Planus A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Lichen planus is an inflammatory disorder of unknown aetiology affecting the stratified squamous epithelia with an estimated global prevalence of 022 to 05 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None