ClinicalTrials.gg
Not yet recruitingNCT07432386Updated May 15, 2026

Methotrexate Versus Apremilast for Pruritus in Psoriasis

A Phase 4 interventional study of Apremilast and Methotrexate in Psoriasis and Pruritus, sponsored by Zarmeen Khawar. Not yet recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-15.

Sponsored by Zarmeen Khawar · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Psoriasis
  • Pruritus

Keywords

  • Methotrexate Apremilast Randomized Controlled Trial Dermatology Life Quality Index DLQI Psoriasis Treatment Itch Severity Numerical Rating Scale
03

In context

Psoriasis

2,028 studies on the registry are indexed under Psoriasis; 275 are open to participants now.

This study's planned enrollment of 80 is close to the median of 75 across 1,565 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

This is the only study on the registry with Zarmeen Khawar as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .
  • Patients able to comply with study protocol and follow-up visits.

Exclusion criteria

Exclusion Criteria:

  • - Pregnant or lactating women.
  • Patients with severe hepatic or renal impairment.
  • Patients with known to Methotrexate or Apremilast.
  • Patients currently receiving systemic therapy for psoriasis within the last 4 weeks.
  • Patients with active infections, including tuberculosis.
  • Patients with .
  • Patients with significant hematological abnormalities.
  • Patients unwilling to provide .
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Apremilast Group

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

    Drug: Apremilast

  • Experimental
    Methotrexate Group

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

    Drug: Methotrexate

Interventions

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

  • Oral Methotrexate 10 mg once weekly for 8 weeks.

06

What researchers measure

Primary outcomes

  1. Change in Dermatology Life Quality Index (DLQI) Score

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

    Time frame: 8 weeks

Secondary outcomes

  1. Change in Pruritus Severity Using Numerical Rating Scale

    Difference between baseline pruritus numerical rating score (0-10 scale) and score at 8 weeks.

    Time frame: 8 weeks

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07432386
Lead sponsor
Zarmeen Khawar
Responsible party
Zarmeen Khawar (FCPS Trainee Dermatology, Pak Emirates Military Hospital) — Sponsor-investigator
First posted
Feb 25, 2026
Start date
May 14, 2026 (estimated)
Primary completion
Oct 14, 2026 (estimated)
Completion
Oct 14, 2026 (estimated)
Last update
May 15, 2026

Study contacts

Zarmeen Khawar, MBBS
Contact
zarmeenkhawar1@gmail.com
+923331940829

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Apremilast · Methotrexate

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