Efficacy of Novel Drug-combinations for Relief of Psoriasis

Psoriasis Clinical Trial

— ENDURE  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02394301
• Other study ID #: Medimix Pharm-04
• Status: Suspended
• Phase: N/A
• First received: March 9, 2015
• Last updated: May 15, 2015
• Start date: February 2015
• Est. completion date: December 2015

Study information

• Verified date: May 2015
• Source: Medimix Specialty Pharmacy, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 200
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Psoriasis

Locations

Country	Name	City	State
United States	The Medimix Specialty Pharmacy, LLC	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Medimix Specialty Pharmacy, LLC

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. Erratum in: JAMA Dermatol. 2014 Mar;150(3):337. JAMA Dermatol. 2014 Jan;150(1):103. — View Citation

Choi J, Koo JY. Quality of life issues in psoriasis. J Am Acad Dermatol. 2003 Aug;49(2 Suppl):S57-61. Review. — View 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. — View Citation

Menter A, Griffiths CE. Current and future management of psoriasis. Lancet. 2007 Jul 21;370(9583):272-84. Review. — View 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. — View 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. Epub 2006 Mar 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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]	No
Secondary	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]	No
Secondary	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]	No