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Not yet recruiting NCT07432386

Methotrexate Versus Apremilast for Pruritus in Psoriasis

Phase IV Interventional Psoriasis Pruritus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Apremilast, Methotrexate.
Who it may be relevant to
Registry conditions: Psoriasis, Pruritus. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Drug Apremilast
    Oral Apremilast titrated to 30 mg twice daily for 8 weeks.
  • Drug Methotrexate
    Oral Methotrexate 10 mg once weekly for 8 weeks.

Primary outcome measures

  • Change in Dermatology Life Quality Index (DLQI) Score [Time frame: 8 weeks]
Secondary outcome measures (1)
  • Change in Pruritus Severity Using Numerical Rating Scale [Time frame: 8 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • Pak Emirates Military Hospital — Rawalpindi

Identifiers

NCT: NCT07432386 · PEMH-DERM-RCT-2026-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗