Roflumilast Versus Methotrexate in Psoriasis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-09

Study Completion Date

2023-05-14

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

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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.

Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Roflumilast

oral roflumilast in a dose of 500 mcg per day

Group Type EXPERIMENTAL

Roflumilast

Intervention Type DRUG

The patients will receive oral roflumilast in a dose of 500 mcg per day for 12 weeks

Methotrexate

oral methotrexate in a dose of 0.2- 0.4 mg/kg/week

Group Type ACTIVE_COMPARATOR

Methotrexate

Intervention Type DRUG

The patients will receive methotrexate in a dose of 0.2- 0.4 mg/kg/week for 12 weeks

Interventions

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Roflumilast

The patients will receive oral roflumilast in a dose of 500 mcg per day for 12 weeks

Intervention Type DRUG

Methotrexate

The patients will receive methotrexate in a dose of 0.2- 0.4 mg/kg/week for 12 weeks

Intervention Type DRUG

Other Intervention Names

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Roflumilast oral Methotrexate tablets

Eligibility Criteria

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Inclusion Criteria

1. Patients with psoriasis vulgaris
2. Psoriatic patients not receiving any relevant systemic treatment for at least 4 weeks before initiation of our study
3. Psoriatic patients not receiving any relevant topical treatment for at least 2 weeks before initiation of our study

Exclusion Criteria

1. Erythrodermic or pustular psoriasis
2. Pregnant and lactating females
3. Patients with autoimmune diseases e.g. systemic lupus erythematosus
4. Patients with solid or hematological malignancies e.g., breast cancer, leukemia, etc.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No