NCT07432386

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
5mo left

Started May 2026

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
May 2026Oct 2026

First Submitted

Initial submission to the registry

February 19, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 25, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

May 14, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2026

Last Updated

May 15, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

February 19, 2026

Last Update Submit

May 13, 2026

Conditions

PsoriasisPruritus

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Change in Dermatology Life Quality Index (DLQI) Score

    Difference between baseline DLQI score and DLQI score at 8 weeks after treatment.

    8 weeks

Secondary Outcomes (1)

  • Change in Pruritus Severity Using Numerical Rating Scale

    8 weeks

Study Arms (2)

Apremilast Group

EXPERIMENTAL

Participants will receive oral Apremilast titrated to 30 mg twice daily for 8 weeks.

Drug: Apremilast

Methotrexate Group

EXPERIMENTAL

Participants will receive oral Methotrexate 10 mg once weekly for 8 weeks.

Drug: Methotrexate

Interventions

ApremilastDRUG

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

Apremilast Group
MethotrexateDRUG

Oral Methotrexate 10 mg once weekly for 8 weeks.

Methotrexate Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pak Emirates Military Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Conditions

PsoriasisPruritus

Interventions

apremilastMethotrexate

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Central Study Contacts

Zarmeen Khawar, MBBS

CONTACT

+923331940829zarmeenkhawar1@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
FCPS Trainee Dermatology

Study Record Dates

First Submitted

February 19, 2026

First Posted

February 25, 2026

Study Start

May 14, 2026

Primary Completion (Estimated)

October 14, 2026

Study Completion (Estimated)

October 14, 2026

Last Updated

May 15, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)