Efficacy of Novel Drug-combinations for Relief of Psoriasis (ENDURE)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Suspended
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Change in Psoriasis Area Severity Index (PASI) Score
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Change in Psoriasis Area Severity Index (PASI) Score
Time Frame: 12 Week Study [Baseline, 2, 4, 8, and 12 week evaluation]
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.
Secondary Outcomes
- Quality of Life(12 Weeks [Baseline, 2, 4, 8, and 12 week evaluation])
- Methotrexate absorption(12 Weeks [Baseline, 4, 12 week evaluation])