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Psoriasis is a long standing inflammatory, autoinflammatory disease linked with many comorbidities. Patients with moderate to severe plaque psoriasis can be managed with topical as well as systemic medications. FDA approved Apremilast as first drug to be taken orally in cases of psoriasis in mid 1990's. Currently, according to researchers best knowledge no study has been done on use of Apremilast in Pakistan. It has recently become available here. Keeping in view all the benefits of this drug, a study has been planned to check its effectiveness and safety 30mg twice a day, in patients with moderate to severe chronic plaque psoriasis based on Psoriasis area and severity index and Body surface area assessments in our population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apremilast 30 mg twice daily | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apremilast 30mg | Drug | Apremilast 30mg twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Psoriasis area and severity index | 16 weeks | |
| body surface area | 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof. Dr. Haroon Nabi | Professor Department of Dermatology LMDC | Study Director |
| Dr. Saira Muaaz | Department of Dermatology Ghurki Hospital | Principal Investigator |
| Dr. Hira Tariq | Senior Registrar Department of Dermatology Services Hospital | Study Chair |
| Dr. Sumera Hanif | Senior Registrar Department of Dermatology LMDC | Study Chair |
| Dr. Talat Akbar | Associate Professor, Dermatology, LMDC | Study Chair |
| Prof. Dr. Faria Asad | Head of Department Dermatology SIMS/ Services Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ghurki Hospital | Lahore | Punjab Province | 54000 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22257911 | Background | Schafer P. Apremilast mechanism of action and application to psoriasis and psoriatic arthritis. Biochem Pharmacol. 2012 Jun 15;83(12):1583-90. doi: 10.1016/j.bcp.2012.01.001. Epub 2012 Jan 10. | |
| 28416342 | Background | Crowley J, Thaci D, Joly P, Peris K, Papp KA, Goncalves J, Day RM, Chen R, Shah K, Ferrandiz C, Cather JC. Long-term safety and tolerability of apremilast in patients with psoriasis: Pooled safety analysis for >/=156 weeks from 2 phase 3, randomized, controlled trials (ESTEEM 1 and 2). J Am Acad Dermatol. 2017 Aug;77(2):310-317.e1. doi: 10.1016/j.jaad.2017.01.052. Epub 2017 Apr 14. |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C505730 | apremilast |
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