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Completed

NCT Number: NCT03791216

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

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.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fasting blood draw for lipid assessments

Other

Fasting blood draw for lipid assessments

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Children's Hospital of Philadelphia
  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Psoriasis Foundation
  • Radboud University Medical Center

Registry information

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Jan 2, 2019
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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