Efficacy of Novel Drug-combinations for Relief of Psoriasis

NCT02394301 | Suspended DMC

• 1 other identifier: Medimix Pharm-04
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Keywords

Efficacy of Novel Drug Combinations for Relief of Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Quality of Life

  12 Weeks [Baseline, 2, 4, 8, and 12 week evaluation]

• Methotrexate absorption

  12 Weeks [Baseline, 4, 12 week evaluation]

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants with psoriasis vulgaris that are prescribed a combination compounded topical psoriasis formulation.

You may qualify if:

• \>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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medimix Specialty Pharmacy, LLC: lead

Study Sites (1)

The Medimix Specialty Pharmacy, LLC

Jacksonville, Florida, 32216, United States

Location

Related Publications (6)

• 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.

  PMID: 17658398 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.

  PMID: 19962785 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.

  PMID: 12894127 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.

  PMID: 16575395 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.

  PMID: 10906652 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.

  PMID: 23945732 BACKGROUND

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Benjamin J Epstein, PharmD

  Medimix Specialty Pharmacy

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2015
• First Posted: March 20, 2015
• Study Start: February 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 18, 2015

Record last verified: 2015-05

Locations

US (1)