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

Active, not recruiting

• Conditions: Psoriasis
• Interventions: Other: Fasting blood draw for lipid assessments

• Registration Number: NCT03791216
• Lead Sponsor: Northwestern University

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 available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-12-01
• Study First Submitted: 2018-12-05
• Study First Submitted QC: 2018-12-29
• Study First Posted: 2019-01-02
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-13
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 62

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Psoriasis patients to be treated only topically	Fasting blood draw for lipid assessments	-
Patients being treated with isotretinoin for acne	Fasting blood draw for lipid assessments	-
Age-, sex- and BMI percentile-matched controls	Fasting blood draw for lipid assessments	-
Psoriasis patients with moderate-to-severe psoriasis who begin	Fasting blood draw for lipid assessments	-

Primary Outcome Measures

Name	Time	Method
Lipoprotein composition differences-glucose	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-c-reactive protein	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-apolipoprotein	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	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.
Lipoprotein composition differences-insulin	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-lipid concentration	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	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.

Trial Locations

Locations (1)

Ann & Robert H. Lurie Children's Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States