PsoriasisPhase 4NCT07432386
Methotrexate Versus Apremilast for Pruritus in Psoriasis
A Phase 4 study testing Apremilast and Methotrexate in people with Psoriasis and Pruritus, run by Zarmeen Khawar at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- Apremilast and Methotrexate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- 14 May 2026to 14 Oct 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- - 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Pak Emirates Military Hospital
Rawalpindi, Punjab Province, 46000
Zarmeen Khawar, MBBS, +923331940829, zarmeenkhawar1@gmail.com
About this study
Official title: Comparison of Efficacy of Methotrexate Versus Apremilast in the Treatment of Pruritus in Psoriasis: A Randomized Controlled Trial
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.
- Being tested
- Apremilast, Methotrexate
- Keywords
- Methotrexate Apremilast Randomized Controlled Trial Dermatology Life Quality Index DLQI Psoriasis Treatment Itch Severity Numerical Rating Scale
- Medical subject headings
- Psoriasis, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApremilastDrug
Oral Apremilast titrated to 30 mg twice daily for 8 weeks.
MethotrexateDrug
Oral Methotrexate 10 mg once weekly for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Apremilast Group | Experimental | Participants will receive oral Apremilast titrated to 30 mg twice daily for 8 weeks. Receives: Drug: Apremilast |
| Methotrexate Group | Experimental | Participants will receive oral Methotrexate 10 mg once weekly for 8 weeks. Receives: Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Dermatology Life Quality Index (DLQI) Score
Difference between baseline DLQI score and DLQI score at 8 weeks after treatment.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start14 May 2026 (estimated)
- Primary completion14 Oct 2026 (estimated)
- Study completion14 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zarmeen Khawar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zarmeen Khawar, Pak Emirates Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07432386
- Sponsor's protocol ID
- PEMH-DERM-RCT-2026-01
- Status last verified
- Feb 2026
- First submitted
- 19 Feb 2026
- Last updated
- 15 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of Methotrexate Versus Apremilast in the Treatment of Pruritus in Psoriasis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07432386
- Acronym / sponsor ID
- PEMH-DERM-RCT-2026-01
- Keywords
- Methotrexate Apremilast Randomized Controlled Trial Dermatology Life Quality Index DLQI Psoriasis Treatment Itch Severity Numerical Rating Scale
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Zarmeen KhawarUniversity, hospital or other
- Study start
- 14 May 2026 (estimated)
- Primary completion
- 14 Oct 2026 (estimated)
- Study completion
- 14 Oct 2026 (estimated)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apremilast Group | Experimental | Drug: ApremilastParticipants will receive oral Apremilast titrated to 30 mg twice daily for 8 weeks. |
| Methotrexate Group | Experimental | Drug: MethotrexateParticipants will receive oral Methotrexate 10 mg once weekly for 8 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- - 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApremilastOral Apremilast titrated to 30 mg twice daily for 8 weeks. | Drug | Apremilast Group |
| MethotrexateOral Methotrexate 10 mg once weekly for 8 weeks. | Drug | Methotrexate Group |
Primary outcome
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.
1 secondary outcome
Change in Pruritus Severity Using Numerical Rating Scale
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Apremilast and Methotrexate in people with Psoriasis and Pruritus, run by Zarmeen Khawar at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zarmeen Khawar, MBBS (+923331940829, zarmeenkhawar1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Dermatology Life Quality Index (DLQI) Score (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.