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

Northwestern University

Status: Active, not recruiting

Conditions: Psoriasis

Treatments: Other: Fasting blood draw for lipid assessments

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03791216

2019-2361

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

62 participants in 4 patient groups

Psoriasis patients to be treated only topically

Treatment:

Other: Fasting blood draw for lipid assessments

Psoriasis patients with moderate-to-severe psoriasis who begin

Treatment:

Other: Fasting blood draw for lipid assessments

Age-, sex- and BMI percentile-matched controls

Treatment:

Other: Fasting blood draw for lipid assessments

Patients being treated with isotretinoin for acne

Treatment:

Other: Fasting blood draw for lipid assessments