Roflumilast Versus Methotrexate in Psoriasis

Study Overview
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Brief Summary
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Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor, which is approved in its oral form for chronic obstructive pulmonary disease, and in its topical form in the treatment of plaque psoriasis. Methotrexate is one of the conventional systemic treatments of psoriasis, so the aim of this study is to compare the efficacy and safety of roflumilast and methotrexate in the treatment of psoriasis

Detailed Description
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Phosphodiesterase (PDE-4) activity was found to be greater in psoriatic skin than in healthy skin. Inhibition of PDE-4 inhibits the hydrolysis of cyclic AMP in inflammatory cells, which increases intracellular cAMP and results in down-regulation of immune modulators, including tumor necrosis factor (TNF)- α, interferon-γ, interleukin (IL)-17, and IL-23. Roflumilast is a potent and selective inhibitor of PDE-4 which is already approved in its oral form for chronic obstructive pulmonary disease. Regarding Roflumilast's topical form, it is currently also approved in the treatment of psoriasis. Lebwohl et al., 2020 found that roflumilast cream was efficacious in reducing the severity of psoriasis in a 12-week, randomized, double-blind, placebo vehicle-controlled trial.

Official Title
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Roflumilast Versus Methotrexate in the Treatment of Psoriasis

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: Roflumilast
* Drug: Methotrexate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with psoriasis vulgaris Psoriatic patients not receiving any relevant systemic treatment for at least 4 weeks before initiation of our study Psoriatic patients not receiving any relevant topical treatment for at least 2 weeks before initiation of our study Exclusion Criteria: Erythrodermic or pustular psoriasis Pregnant and lactating females Patients with autoimmune diseases e.g. systemic lupus erythematosus Patients with solid or hematological malignancies e.g., breast cancer, leukemia, etc.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Roflumilast<br>oral roflumilast in a dose of 500 mcg per day | Drug: Roflumilast<br>* The patients will receive oral roflumilast in a dose of 500 mcg per day for 12 weeks<br>* Other names: Roflumilast oral;|
| Active Comparator: Methotrexate<br>oral methotrexate in a dose of 0.2- 0.4 mg/kg/week | Drug: Methotrexate<br>* The patients will receive methotrexate in a dose of 0.2- 0.4 mg/kg/week for 12 weeks<br>* Other names: Methotrexate tablets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psoriasis Severity Index (PASI) before and after Roflumilast | Comparison of Psoriasis Severity Index (PASI) before and after treatment with Roflumilast, where the lower score indicates clinical improvement. PASI score ranges from 0-72. | 12 weeks | 
| Psoriasis Severity Index (PASI) change with Roflumilast Vs Methotrexate | Comparison of change of Psoriasis Severity Index (PASI) after treatment with roflumilast and after treatment of methotrexate where the lower score indicates clinical improvement. PASI score ranges from 0-72. | 12 weeks |