Methotrexate Versus Apremilast for Pruritus in Psoriasis

May 13, 2026 updated by: Zarmeen Khawar

Comparison of Efficacy of Methotrexate Versus Apremilast in the Treatment of Pruritus in Psoriasis: A Randomized Controlled Trial

This randomized controlled trial aims to compare the efficacy of Methotrexate versus Apremilast in reducing pruritus and improving quality of life in patients with psoriasis. Eighty patients aged 20 to 60 years with psoriasis involving more than 8% body surface area and associated pruritus will be enrolled and randomly assigned into two groups. Group A will receive oral Apremilast titrated to 30 mg twice daily, while Group B will receive oral Methotrexate 10 mg once weekly for 8 weeks. The primary outcome will be change in Dermatology Life Quality Index (DLQI) score at 8 weeks. Secondary outcomes include change in numerical rating scale for pruritus and assessment of adverse effects. The study will be conducted at Pakistan Emirates Military Hospital Rawalpindi.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 4

Contacts and Locations

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

Study Contact

Study Locations

  • Pakistan
    • Punjab Province
      • Rawalpindi, Punjab Province, Pakistan, 46000
        • Pak Emirates Military Hospital
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male and female patients aged 18 to 65 years.
  • Clinically diagnosed cases of psoriasis.
  • Patients experiencing pruritus associated with psoriasis.
  • Patients willing to participate and provide written informed consent.
  • Patients able to comply with study protocol and follow-up visits.

Exclusion Criteria:

  • - Pregnant or lactating women.
  • Patients with severe hepatic or renal impairment.
  • Patients with known hypersensitivity to Methotrexate or Apremilast.
  • Patients currently receiving systemic therapy for psoriasis within the last 4 weeks.
  • Patients with active infections, including tuberculosis.
  • Patients with malignancy.
  • Patients with significant hematological abnormalities.
  • Patients unwilling to provide informed consent.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Apremilast Group
Participants will receive oral Apremilast titrated to 30 mg twice daily for 8 weeks.
Drug: Apremilast
Oral Apremilast titrated to 30 mg twice daily for 8 weeks.
Experimental: Methotrexate Group
Participants will receive oral Methotrexate 10 mg once weekly for 8 weeks.
Drug: Methotrexate
Oral Methotrexate 10 mg once weekly for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Dermatology Life Quality Index (DLQI) Score
Time Frame: 8 weeks
Difference between baseline DLQI score and DLQI score at 8 weeks after treatment.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pruritus Severity Using Numerical Rating Scale
Time Frame: 8 weeks
Difference between baseline pruritus numerical rating score (0-10 scale) and score at 8 weeks.
8 weeks

Collaborators and Investigators

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

Sponsor

Zarmeen Khawar

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 (Estimated)

May 14, 2026

Primary Completion (Estimated)

October 14, 2026

Study Completion (Estimated)

October 14, 2026

Study Registration Dates

First Submitted

February 19, 2026

First Submitted That Met QC Criteria

February 19, 2026

First Posted (Actual)

February 25, 2026

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEMH-DERM-RCT-2026-01

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

No

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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