NCT05684744

Roflumilast Versus Methotrexate in Psoriasis

Roflumilast Versus Methotrexate in the Treatment of Psoriasis

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

• Psoriasis

Interventions

Type	Name	Description
DRUG	Roflumilast	The patients will receive oral roflumilast in a dose of 500 mcg per day for 12 weeks
DRUG	Methotrexate	The patients will receive methotrexate in a dose of 0.2- 0.4 mg/kg/week for 12 weeks

Timeline

• Start date: 2023-01-09
• Primary completion: 2023-05-09
• Completion: 2023-05-14
• First posted: 2023-01-13
• Last updated: 2023-05-16

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study