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

NCT03791216 | Completed

• 1 other identifier: 2019-2361
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (7)

• Lipoprotein composition differences-glucose

  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.

  one year

• Lipoprotein composition differences-insulin

  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.

  one year

• Lipoprotein composition differences-c-reactive protein

  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.

  one year

• Lipoprotein composition differences-lipid concentration

  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.

  one year

• Lipoprotein composition differences-chemistry panel

  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.

  one year

• Lipoprotein composition differences-apolipoprotein

  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.

  one year

• Lipoprotein composition differences-NMR

  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.

  one year

Study Arms (4)

Psoriasis patients to be treated only topically

Other: Fasting blood draw for lipid assessments

Psoriasis patients with moderate-to-severe psoriasis who begin

Other: Fasting blood draw for lipid assessments

Age-, sex- and BMI percentile-matched controls

Other: Fasting blood draw for lipid assessments

Patients being treated with isotretinoin for acne

Other: Fasting blood draw for lipid assessments

Interventions

Fasting blood draw for lipid assessments OTHER

Fasting blood draw for lipid assessments

Age-, sex- and BMI percentile-matched controls; Patients being treated with isotretinoin for acne; Psoriasis patients to be treated only topically; Psoriasis patients with moderate-to-severe psoriasis who begin

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

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

Chicago, Illinois, 60611, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples for lipids testing

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

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

Study Officials

• Amy Paller, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: January 2, 2019
• Study Start: December 1, 2018
• Primary Completion: June 18, 2025
• Study Completion: June 18, 2025
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)