Back to resultsRoflumilast Versus Methotrexate in Psoriasis
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Roflumilast
Methotrexate
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility Criteria
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.
Sites / Locations
- Cairo University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Roflumilast
Methotrexate
Arm Description
oral roflumilast in a dose of 500 mcg per day
oral methotrexate in a dose of 0.2- 0.4 mg/kg/week
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05684744
Brief Title
Roflumilast Versus Methotrexate in Psoriasis
Official Title
Roflumilast Versus Methotrexate in the Treatment of Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 9, 2023 (Actual)
Primary Completion Date
May 9, 2023 (Actual)
Study Completion Date
May 14, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Roflumilast
Arm Type
Experimental
Arm Description
oral roflumilast in a dose of 500 mcg per day
Arm Title
Methotrexate
Arm Type
Active Comparator
Arm Description
oral methotrexate in a dose of 0.2- 0.4 mg/kg/week
Intervention Type
Drug
Intervention Name(s)
Roflumilast
Other Intervention Name(s)
Roflumilast oral
Intervention Description
The patients will receive oral roflumilast in a dose of 500 mcg per day for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Other Intervention Name(s)
Methotrexate tablets
Intervention Description
The patients will receive methotrexate in a dose of 0.2- 0.4 mg/kg/week for 12 weeks
Primary Outcome Measure Information:
Title
Psoriasis Severity Index (PASI) before and after Roflumilast
Description
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
Title
Psoriasis Severity Index (PASI) change with Roflumilast Vs Methotrexate
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Roflumilast Versus Methotrexate in Psoriasis
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