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NCT Number: NCT07432386

Methotrexate Versus Apremilast for Pruritus in Psoriasis

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.

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Key information

Conditions

Psoriasis Pathological Conditions, Signs and Symptoms Pruritus Signs and Symptoms Skin Diseases Skin Diseases, Papulosquamous Skin Manifestations Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pak Emirates Military Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

Location contact

Zarmeen Khawar, MBBS

CONTACT

[email protected]

+923331940829

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Apremilast

Drug

Oral Apremilast titrated to 30 mg twice daily for 8 weeks.

methotrexate

Drug

Oral Methotrexate 10 mg once weekly for 8 weeks.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Zarmeen Khawar, MBBS

CONTACT

[email protected]

+923331940829

Sponsors and collaborators

Lead sponsor

Zarmeen Khawar

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 25, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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