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

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ClinicalTrials.gov Identifier: NCT02394301
Recruitment Status : Suspended (Poor enrollment)
First Posted : March 20, 2015
Last Update Posted : May 18, 2015
Sponsor:
Information provided by (Responsible Party):
Medimix Specialty Pharmacy, LLC

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.

Condition or disease
Psoriasis

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Weeks
Official Title: Efficacy of Novel Drug-combinations for Relief of Psoriasis (ENDURE)
Study Start Date : February 2015
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Quality of Life [ Time Frame: 12 Weeks [Baseline, 2, 4, 8, and 12 week evaluation] ]
    To assess change in quality of life, the Skindex-16 assessment tool will be used at all study visits.

  2. Methotrexate absorption [ Time Frame: 12 Weeks [Baseline, 4, 12 week evaluation] ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult participants with psoriasis vulgaris that are prescribed a combination compounded topical psoriasis formulation.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02394301


Locations
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United States, Florida
The Medimix Specialty Pharmacy, LLC
Jacksonville, Florida, United States, 32216
Sponsors and Collaborators
Medimix Specialty Pharmacy, LLC
Investigators
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Study Chair: Benjamin J Epstein, PharmD Medimix Specialty Pharmacy

Additional Information:

Publications:

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Responsible Party: Medimix Specialty Pharmacy, LLC
ClinicalTrials.gov Identifier: NCT02394301     History of Changes
Other Study ID Numbers: Medimix Pharm-04
First Posted: March 20, 2015    Key Record Dates
Last Update Posted: May 18, 2015
Last Verified: May 2015
Keywords provided by Medimix Specialty Pharmacy, LLC:
Efficacy of Novel Drug Combinations for Relief of Psoriasis
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases