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

Study Overview
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Brief Summary
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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.

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

Conditions
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Psoriasis

Intervention / Treatment
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* Other: Fasting blood draw for lipid assessments


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Psoriasis patients to be treated only topically<br> | Other: Fasting blood draw for lipid assessments<br>* Fasting blood draw for lipid assessments<br>|
| Psoriasis patients with moderate-to-severe psoriasis who begin<br> | Other: Fasting blood draw for lipid assessments<br>* Fasting blood draw for lipid assessments<br>|
| Age-, sex- and BMI percentile-matched controls<br> | Other: Fasting blood draw for lipid assessments<br>* Fasting blood draw for lipid assessments<br>|
| Patients being treated with isotretinoin for acne<br> | Other: Fasting blood draw for lipid assessments<br>* Fasting blood draw for lipid assessments<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |