A Phase 2/3 interventional study of Roflumilast and Methotrexate in Psoriasis, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-16.
Sponsored by Cairo University · Phase 2/3, Interventional, and Treatment
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
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.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 30 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
oral roflumilast in a dose of 500 mcg per day
Drug: Roflumilast
oral methotrexate in a dose of 0.2- 0.4 mg/kg/week
Drug: Methotrexate
The patients will receive oral roflumilast in a dose of 500 mcg per day for 12 weeks
Also known as: Roflumilast oral
The patients will receive methotrexate in a dose of 0.2- 0.4 mg/kg/week for 12 weeks
Also known as: Methotrexate tablets
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.
Time frame: 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.
Time frame: 12 weeks
Plan to share: No
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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Cairo University