Clincosm LogoSign in Get a demo

Roflumilast Versus Methotrexate in Psoriasis

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05684744
Collaborator
(none)
30
Enrollment
2
Arms
3.2
Anticipated Duration (Months)

Study Details

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

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Roflumilast Versus Methotrexate in the Treatment of Psoriasis
Anticipated Study Start Date :
Jan 9, 2023
Anticipated Primary Completion Date :
Apr 9, 2023
Anticipated Study Completion Date :
Apr 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Roflumilast

oral roflumilast in a dose of 500 mcg per day

Drug: Roflumilast
The patients will receive oral roflumilast in a dose of 500 mcg per day for 12 weeks
Other Names:
  • Roflumilast oral

    		•
    Active Comparator: Methotrexate

    oral methotrexate in a dose of 0.2- 0.4 mg/kg/week

    Drug: Methotrexate
    The patients will receive methotrexate in a dose of 0.2- 0.4 mg/kg/week for 12 weeks
    Other Names:
  • Methotrexate tablets

    		•

    Outcome Measures

    Primary Outcome Measures

    1. PASI before and after Roflumilast [12 weeks]

      Comparison of Psoriasis Severity Index (PASI) before and after treatment with Roflumilast

    2. PASI change with Roflumilast Vs Methotrexate [12 weeks]

      Comparison of change of PASI after treatment with roflumilast and after treatment of methotrexate

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Cairo University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dina Saadi, Associate Professor of Dermatology, Cairo University
    ClinicalTrials.gov Identifier:
    NCT05684744
    Other Study ID Numbers:
    • Kapu27
    First Posted:
    Jan 13, 2023
    Last Update Posted:
    Jan 13, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Psoriasis
    Methotrexate

    Study Results

    No Results Posted as of Jan 13, 2023