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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apremilast Group | Experimental | Participants will receive oral Apremilast titrated to 30 mg twice daily for 8 weeks. |
|
| Methotrexate Group | Experimental | Participants will receive oral Methotrexate 10 mg once weekly for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apremilast | Drug | Oral Apremilast titrated to 30 mg twice daily for 8 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Dermatology Life Quality Index (DLQI) Score | Difference between baseline DLQI score and DLQI score at 8 weeks after treatment. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pruritus Severity Using Numerical Rating Scale | Difference between baseline pruritus numerical rating score (0-10 scale) and score at 8 weeks. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zarmeen Khawar, MBBS | Contact | +923331940829 | zarmeenkhawar1@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pak Emirates Military Hospital | Rawalpindi | Punjab Province | 46000 | Pakistan |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
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| ID | Term |
|---|---|
| C505730 | apremilast |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Methotrexate |
| Drug |
Oral Methotrexate 10 mg once weekly for 8 weeks. |
|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |