Methotrexate Versus Apremilast for Pruritus in Psoriasis

ConditionsPsoriasis Pruritus

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18-65

SponsorZarmeen Khawar

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

- 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.

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

80 Participants

are divided into 2 treatment groups

Group A: Apremilast GroupExperimental treatment 1 intervention

Group B: Methotrexate GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zarmeen Khawar

Lead sponsor

Pak Emirates Military Hospital

Sponsor institution

Source ClinicalTrials.gov

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