Roflumilast Versus Methotrexate in Psoriasis

Phase 2

Completed

• Conditions: Psoriasis
• Interventions: Drug: Roflumilast; Drug: Methotrexate

• Registration Number: NCT05684744
• Lead Sponsor: Cairo University

Brief 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.

Study Timeline

• Study First Submitted: 2023-01-05
• Study First Submitted QC: 2023-01-05
• Study Start: 2023-01-09
• Study First Posted: 2023-01-13
• Status Verified: 2023-05
• Primary Completion: 2023-05-09
• Study Completion: 2023-05-14
• Last Update Submitted: 2023-05-14
• Last Update Posted: 2023-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Roflumilast	Roflumilast	oral roflumilast in a dose of 500 mcg per day
Methotrexate	Methotrexate	oral methotrexate in a dose of 0.2- 0.4 mg/kg/week

Primary Outcome Measures

Name	Time	Method
Psoriasis Severity Index (PASI) before and after Roflumilast	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.
Psoriasis Severity Index (PASI) change with Roflumilast Vs Methotrexate	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.

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt