Roflumilast Versus Methotrexate in Psoriasis

May 14, 2023 updated by: Dina Saadi, Cairo University

Roflumilast Versus Methotrexate in the Treatment of Psoriasis

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psoriasis Severity Index (PASI) before and after Roflumilast
Time Frame: 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.
12 weeks
Psoriasis Severity Index (PASI) change with Roflumilast Vs Methotrexate
Time Frame: 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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2023

Primary Completion (Actual)

May 9, 2023

Study Completion (Actual)

May 14, 2023

Study Registration Dates

First Submitted

January 5, 2023

First Submitted That Met QC Criteria

January 5, 2023

First Posted (Actual)

January 13, 2023

Study Record Updates

Last Update Posted (Actual)

May 16, 2023

Last Update Submitted That Met QC Criteria

May 14, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Kapu27

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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