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

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03791216
• Other study ID #: 2019-2361
• Status: Active, not recruiting
• Start date: December 1, 2018
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 62
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Other:
• Fasting blood draw for lipid assessments
Fasting blood draw for lipid assessments

Locations

Country	Name	City	State
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois

Sponsors (5)

Lead Sponsor	Collaborator
Northwestern University	Children's Hospital of Philadelphia, National Heart, Lung, and Blood Institute (NHLBI), National Psoriasis Foundation, Radboud University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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