Psoriasis
Conditions
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.
Interventions
OTHERFasting blood draw for lipid assessments
Fasting blood draw for lipid assessments
Sponsors
National Psoriasis Foundation
National Heart, Lung, and Blood Institute (NHLBI)
Children's Hospital of Philadelphia
Radboud University Medical Center
Northwestern University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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-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-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-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. |
| 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. |
Countries
United States
Outcome results
None listed