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Characterization of Lipoprotein Composition and Function in Pediatric Psoriasis Before and After Treatment

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ClinicalTrials.gov Identifier: NCT03791216
Recruitment Status : Recruiting
First Posted : January 1, 2019
Last Update Posted : January 1, 2019
Sponsor:
Collaborators:
National Psoriasis Foundation
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Amy Paller, Northwestern University

Tracking Information
First Submitted Date December 5, 2018
First Posted Date January 1, 2019
Last Update Posted Date January 1, 2019
Actual Study Start Date December 1, 2018
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 29, 2018)
  • Lipoprotein composition differences-glucose [ Time Frame: one year ]
    To assess differences in the blood concentration levels at baseline for glucose in moderate-to-severe pediatric psoriasis at baseline who begin systemically administered therapy vs: a) healthy controls; and b) patients with milder psoriasis.
  • Lipoprotein composition differences-insulin [ Time Frame: one year ]
    To assess differences in the blood concentration levels at baseline for insulin in moderate-to-severe pediatric psoriasis at baseline who begin systemically administered therapy vs: a) healthy controls; and b) patients with milder psoriasis.
  • Lipoprotein composition differences-c-reactive protein [ Time Frame: one year ]
    To assess differences in the blood concentration levels at baseline for c-reactive protein in moderate-to-severe pediatric psoriasis at baseline who begin systemically administered therapy vs: a) healthy controls; and b) patients with milder psoriasis.
  • Lipoprotein composition differences-lipid concentration [ Time Frame: one year ]
    To assess differences in the blood concentration levels at baseline for lipid concentration in moderate-to-severe pediatric psoriasis at baseline who begin systemically administered therapy vs: a) healthy controls; and b) patients with milder psoriasis.
  • Lipoprotein composition differences-chemistry panel [ Time Frame: one year ]
    To assess differences in the blood concentration levels at baseline for chemistry panel in moderate-to-severe pediatric psoriasis at baseline who begin systemically administered therapy vs: a) healthy controls; and b) patients with milder psoriasis.
  • Lipoprotein composition differences-apolipoprotein [ Time Frame: one year ]
    To assess differences in the blood concentration levels at baseline for apolipoprotein in moderate-to-severe pediatric psoriasis at baseline who begin systemically administered therapy vs: a) healthy controls; and b) patients with milder psoriasis.
  • Lipoprotein composition differences-NMR [ Time Frame: one year ]
    To assess differences in the blood concentration levels at baseline for NMR derived lipoprotein particle concentrations in moderate-to-severe pediatric psoriasis at baseline who begin systemically administered therapy vs: a) healthy controls; and b) patients with milder psoriasis.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Characterization of Lipoprotein Composition and Function in Pediatric Psoriasis Before and After Treatment
Official Title Characterization of Lipoprotein Composition and Function in Pediatric Psoriasis Before and After Treatment
Brief Summary This study will assess differences in inflammatory proteins, lipoprotein composition, cholesterol efflux and HDL-proteome in moderate-to-severe pediatric psoriasis who at baseline begin systemically administered therapy vs: a) healthy controls; and b) patients with milder psoriasis.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Blood samples for lipids testing
Sampling Method Non-Probability Sample
Study Population The investigators plan to recruit approximately 120 subjects total. Subjects will be divided into 4 groups: i) patients to be treated only topically (n=30); ii) patients with moderate-to-severe psoriasis who begin systemic treatment (n=30; ~15 DMARDs and 15 biologics); iii) age-, sex- and BMI percentile-matched controls (n=30); iv) patients being treated with isotretinoin for acne (n=30).
Condition Psoriasis
Intervention Other: Fasting blood draw for lipid assessments
Fasting blood draw for lipid assessments
Study Groups/Cohorts
  • Psoriasis patients to be treated only topically
    Intervention: Other: Fasting blood draw for lipid assessments
  • Psoriasis patients with moderate-to-severe psoriasis who begin
    Intervention: Other: Fasting blood draw for lipid assessments
  • Age-, sex- and BMI percentile-matched controls
    Intervention: Other: Fasting blood draw for lipid assessments
  • Patients being treated with isotretinoin for acne
    Intervention: Other: Fasting blood draw for lipid assessments
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 29, 2018)
120
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Children ages 6-17 years of all races/ethnicities with plaque and/or extensive guttate psoriasis for at least 6 months and on topical or systemic therapy
  • Patients in the systemic group can be starting a medication for the first time OR transitioning from another systemic if unresponsive and on that previous treatment for ≤ 3 months.
  • Patients may concurrently have psoriatic arthritis if initiation of a systemic medication is warranted by skin severity.
  • Children ages 6-17 years of all races/ethnicities with acne being treated with isotretinoin
  • Children ages 6-17 years of all races/ethnicities without plaque or guttate psoriasis and history of severe acne or treatment with isotretinoin as controls.

Exclusion Criteria:

  • Patients less than 6 years of age or 18 years and older
  • Patients with congenital heart disease, prior cardiac catheterizations/surgeries, or on cardiac medications in the past two years other than for hypertension (eg, calcium channel-blockers, beta-blockers and vasotropic medications).
  • Patients who have other systemic inflammatory diseases (including atopic dermatitis, severe acne, inflammatory bowel disease, juvenile idiopathic arthritis, connective tissue diseases and/or other autoimmune diseases).
  • Patients who have active infection or malignancy or have suffered from infection requiring oral or parenteral antibiotic in past 2 weeks.
  • Patients and parents/caregivers unable to give written informed consent.
Sex/Gender
Sexes Eligible for Study: All
Ages 6 Years to 17 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts
Contact: DermatologyCTU 312-503-5944 NUderm-research@northwestern.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03791216
Other Study ID Numbers 2019-2361
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Amy Paller, Northwestern University
Study Sponsor Northwestern University
Collaborators
  • National Psoriasis Foundation
  • National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Amy Paller, MD Northwestern University
PRS Account Northwestern University
Verification Date December 2018