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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

Tracking Information
First Submitted Date March 9, 2015
First Posted Date March 20, 2015
Last Update Posted Date May 18, 2015
Study Start Date February 2015
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 16, 2015)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 16, 2015)
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Efficacy of Novel Drug-combinations for Relief of Psoriasis
Official Title Efficacy of Novel Drug-combinations for Relief of Psoriasis (ENDURE)
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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 12 Weeks
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adult participants with psoriasis vulgaris that are prescribed a combination compounded topical psoriasis formulation.
Condition Psoriasis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Suspended
Estimated Enrollment
 (submitted: March 16, 2015)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2015
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02394301
Other Study ID Numbers Medimix Pharm-04
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Medimix Specialty Pharmacy, LLC
Study Sponsor Medimix Specialty Pharmacy, LLC
Collaborators Not Provided
Investigators
Study Chair: Benjamin J Epstein, PharmD Medimix Specialty Pharmacy
PRS Account Medimix Specialty Pharmacy, LLC
Verification Date May 2015