Clinical trial NCT02394301: Efficacy of Novel Drug-combinations for Relief of Psoriasis
Official title: Efficacy of Novel Drug-combinations for Relief of Psoriasis (ENDURE)
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Psoriasis
Keywords: Efficacy of Novel Drug Combinations for Relief of Psoriasis
Lead sponsor: Medimix Specialty Pharmacy, LLC
Sponsor class: INDUSTRY
First posted: 2015-03-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants with psoriasis vulgaris that are prescribed a combination compounded topical psoriasis formulation.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Psoriasis Area Severity Index (PASI) Score
timeFrame: 12 Week Study [Baseline, 2, 4, 8, and 12 week evaluation]
Secondary outcomes:
measure: Quality of Life
timeFrame: 12 Weeks [Baseline, 2, 4, 8, and 12 week evaluation]
measure: Methotrexate absorption
timeFrame: 12 Weeks [Baseline, 4, 12 week evaluation]
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: The Medimix Specialty Pharmacy, LLC
state: Florida
Study officials:
affiliation: Medimix Specialty Pharmacy
name: Benjamin J Epstein, PharmD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.