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

NCT ID: NCT03791216

Last Updated: 2025-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

62 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-01

Study Completion Date

2025-06-18

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.

Detailed Description

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Conditions

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Psoriasis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Psoriasis patients to be treated only topically

Fasting blood draw for lipid assessments

Intervention Type OTHER

Fasting blood draw for lipid assessments

Psoriasis patients with moderate-to-severe psoriasis who begin

Fasting blood draw for lipid assessments

Intervention Type OTHER

Fasting blood draw for lipid assessments

Age-, sex- and BMI percentile-matched controls

Fasting blood draw for lipid assessments

Intervention Type OTHER

Fasting blood draw for lipid assessments

Patients being treated with isotretinoin for acne

Fasting blood draw for lipid assessments

Intervention Type OTHER

Fasting blood draw for lipid assessments

Interventions

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Fasting blood draw for lipid assessments

Fasting blood draw for lipid assessments

Intervention Type OTHER

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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Psoriasis Foundation

OTHER

Sponsor Role collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Amy Paller

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amy Paller, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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2019-2361

Identifier Type: -

Identifier Source: org_study_id

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