Methotrexate Versus Apremilast for Pruritus in Psoriasis

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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07432386

Enrollment

Registered

2026-02-25

Start date

2026-05-14

Completion date

2026-10-14

Last updated

2026-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pruritus, Psoriasis

Keywords

Methotrexate Apremilast Randomized Controlled Trial Dermatology Life Quality Index DLQI Psoriasis Treatment Itch Severity Numerical Rating Scale

Brief summary

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

DRUGApremilast

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

DRUGMethotrexate

Oral Methotrexate 10 mg once weekly for 8 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

Pakistan

Contacts

CONTACTZarmeen Khawar, MBBS

zarmeenkhawar1@gmail.com+923331940829

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 16, 2026