Clinical trial NCT03791216: Characterization of Lipoprotein Composition and Function in Pediatric Psoriasis Before and After Treatment
Official title: Characterization of Lipoprotein Composition and Function in Pediatric Psoriasis Before and After Treatment
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Psoriasis
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Psoriasis Foundation
name: National Heart, Lung, and Blood Institute (NHLBI)
name: Children's Hospital of Philadelphia
name: Radboud University Medical Center
First posted: 2019-01-02
Enrollment: 62
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators plan to recruit approximately 120 subjects total. Subjects will be divided into 4 groups: i) patients to be treated only topically (n=30); ii) patients with moderate-to-severe psoriasis who begin systemic treatment (n=30; \~15 DMARDs and 15 biologics); iii) age-, sex- and BMI percentile-matched controls (n=30); iv) patients being treated with isotretinoin for acne (n=30).

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Lipoprotein composition differences-glucose
timeFrame: one year
measure: Lipoprotein composition differences-insulin
timeFrame: one year
measure: Lipoprotein composition differences-c-reactive protein
timeFrame: one year
measure: Lipoprotein composition differences-lipid concentration
timeFrame: one year
measure: Lipoprotein composition differences-chemistry panel
timeFrame: one year
measure: Lipoprotein composition differences-apolipoprotein
timeFrame: one year
measure: Lipoprotein composition differences-NMR
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
Study officials:
affiliation: Northwestern University
name: Amy Paller, MD
role: PRINCIPAL_INVESTIGATOR
References: