Methotrexate Versus Apremilast for Pruritus in Psoriasis

Sponsor
Zarmeen Khawar
Study ID
NCT07432386
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Feb 25, 2026
Start date
May 14, 2026
Status verified
Feb 2026
Primary completion
Oct 14, 2026
Completion
Oct 14, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Apremilast Group
    Participants will receive 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.

Primary Outcome Measure

Change in Dermatology Life Quality Index (DLQI) Score [ Time Frame: 8 weeks ]

Central Contacts

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