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NCT Number: NCT05684744

Roflumilast Versus Methotrexate in Psoriasis

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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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Cairo University

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Roflumilast

Drug

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

Other names: Roflumilast oral

methotrexate

Drug

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

Other names: Methotrexate tablets

Primary outcomes

  1. Psoriasis Severity Index (PASI) before and after Roflumilast

    Time frame: 12 weeks

    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.

  2. Psoriasis Severity Index (PASI) change with Roflumilast Vs Methotrexate

    Time frame: 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Roflumilast Versus Methotrexate in the Treatment of Psoriasis

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 13, 2023
Registry last updated
May 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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