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Poor enrollment
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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.
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.
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| 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] |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adult participants with psoriasis vulgaris that are prescribed a combination compounded topical psoriasis formulation.
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin J Epstein, PharmD | Medimix Specialty Pharmacy | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Medimix Specialty Pharmacy, LLC | Jacksonville | Florida | 32216 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17658398 | Background | Menter A, Griffiths CE. Current and future management of psoriasis. Lancet. 2007 Jul 21;370(9583):272-284. doi: 10.1016/S0140-6736(07)61129-5. | |
| 19962785 | Background | Tollefson MM, Crowson CS, McEvoy MT, Maradit Kremers H. Incidence of psoriasis in children: a population-based study. J Am Acad Dermatol. 2010 Jun;62(6):979-87. doi: 10.1016/j.jaad.2009.07.029. Epub 2009 Dec 5. |
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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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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] |
| 12894127 | Background | Choi J, Koo JY. Quality of life issues in psoriasis. J Am Acad Dermatol. 2003 Aug;49(2 Suppl):S57-61. doi: 10.1016/s0190-9622(03)01136-8. |
| 16575395 | Background | Unaeze J, Nijsten T, Murphy A, Ravichandran C, Stern RS. Impact of psoriasis on health-related quality of life decreases over time: an 11-year prospective study. J Invest Dermatol. 2006 Jul;126(7):1480-9. doi: 10.1038/sj.jid.5700229. Epub 2006 Mar 30. |
| 10906652 | Background | Krueger GG, Feldman SR, Camisa C, Duvic M, Elder JT, Gottlieb AB, Koo J, Krueger JG, Lebwohl M, Lowe N, Menter A, Morison WL, Prystowsky JH, Shupack JL, Taylor JR, Weinstein GD, Barton TL, Rolstad T, Day RM. Two considerations for patients with psoriasis and their clinicians: what defines mild, moderate, and severe psoriasis? What constitutes a clinically significant improvement when treating psoriasis? J Am Acad Dermatol. 2000 Aug;43(2 Pt 1):281-5. doi: 10.1067/mjd.2000.106374. |
| 23945732 | Background | Armstrong AW, Robertson AD, Wu J, Schupp C, Lebwohl MG. Undertreatment, treatment trends, and treatment dissatisfaction among patients with psoriasis and psoriatic arthritis in the United States: findings from the National Psoriasis Foundation surveys, 2003-2011. JAMA Dermatol. 2013 Oct;149(10):1180-5. doi: 10.1001/jamadermatol.2013.5264. |