Efficacy of Novel Drug-combinations for Relief of Psoriasis

Study Overview
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Brief Summary
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ENDURE is a prospective, observational study aimed to document clinical response and side effects associated with compounded psoriasis medications when prescribed as routine care. As a secondary initiative, this study will assess methotrexate systemic absorption and toxicity in patients prescribed a methotrexate-containing compounded formulation.

Detailed Description
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In this prospective, observational study, change in psoriasis plaque appearance, per the Psoriasis Area Severity Index (PASI) tool, will be evaluated after using a topical psoriasis cream containing at least 3 of the following: corticosteroid, methotrexate, vitamin D3 or synthetic analog, retinoid acid, or urea, or a topical shampoo or spray containing a corticosteroid and vitamin D3 or synthetic analog. The change in quality of life will be assessed during all visits using the Skindex-16 assessment tool. In patients receiving a methotrexate-containing formulation, a sub-study will be available as an option, where laboratory values (methotrexate levels, complete blood count, liver function tests, etc.) will be obtained to confirm that methotrexate absorption is negligible.

Official Title
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Efficacy of Novel Drug-combinations for Relief of Psoriasis (ENDURE)

Conditions
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Psoriasis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 years of age Diagnosis of psoriasis vulgaris Being initiated on a topical compounded medication for psoriasis from Medimix Specialty Pharmacy containing at least 3 of the following ingredients as part of standard of care: corticosteroid, methotrexate, retinoic acid, vitamin D3 or synthetic analog, urea, AND/OR a shampoo/spray containing a corticosteroid and vitamin D3 or synthetic analog for the first time. Exclusion Criteria: Pregnancy & nursing Active infectious disease Kidney abnormalities Blood deficiencies Alcohol consumption Immunodeficiency syndromes History of systemic psoriasis medications, including conventional DMARDs, oral retinoids, oral calcineurin inhibitors, TNF-inhibitors, and monoclonal antibodies within the past 120 days Current or planned use of concomitant psoriasis medications and/or phototherapy Any additional health conditions or concomitant use of other prescription/over-the-counter products that may confound the study results at the discretion of the study investigators

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Psoriasis Area Severity Index (PASI) Score | To evaluate the change in psoriasis plaque resolution, the PASI tool will be utilized. The psoriasis plaques will be evaluated by the overseeing study investigator as part of the normal evaluation of the area. | 12 Week Study [Baseline, 2, 4, 8, and 12 week evaluation] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | To assess change in quality of life, the Skindex-16 assessment tool will be used at all study visits. | 12 Weeks [Baseline, 2, 4, 8, and 12 week evaluation] | 
| Methotrexate absorption | To assess changes in serum methotrexate concentration, methotrexate serum levels and other associated laboratory values (complete blood count, serum creatinine, alanine transaminase, aspartate aminotransferase, C-reactive protein, erythrocyte sedimentation rate, glucose, and insulin levels) will be monitored in patients that agree to participate in the sub-study who are prescribed a methotrexate-containing compounded psoriasis formulation (maximum 25 patients). This outcome measure is a composite. | 12 Weeks [Baseline, 4, 12 week evaluation] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Efficacy of Novel Drug Combinations for Relief of Psoriasis