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

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ClinicalTrials.gov Identifier: NCT03791216
Recruitment Status : Recruiting
First Posted : January 1, 2019
Last Update Posted : January 1, 2019
Sponsor:
Collaborators:
National Psoriasis Foundation
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Amy Paller, Northwestern University

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.

Condition or disease Intervention/treatment
Psoriasis Other: Fasting blood draw for lipid assessments

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Characterization of Lipoprotein Composition and Function in Pediatric Psoriasis Before and After Treatment
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Group/Cohort Intervention/treatment
Psoriasis patients to be treated only topically Other: Fasting blood draw for lipid assessments
Fasting blood draw for lipid assessments

Psoriasis patients with moderate-to-severe psoriasis who begin Other: Fasting blood draw for lipid assessments
Fasting blood draw for lipid assessments

Age-, sex- and BMI percentile-matched controls Other: Fasting blood draw for lipid assessments
Fasting blood draw for lipid assessments

Patients being treated with isotretinoin for acne Other: Fasting blood draw for lipid assessments
Fasting blood draw for lipid assessments




Primary Outcome Measures :
  1. Lipoprotein composition differences-glucose [ Time Frame: one year ]
    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.

  2. Lipoprotein composition differences-insulin [ Time Frame: one year ]
    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.

  3. Lipoprotein composition differences-c-reactive protein [ Time Frame: one year ]
    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.

  4. Lipoprotein composition differences-lipid concentration [ Time Frame: one year ]
    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.

  5. Lipoprotein composition differences-chemistry panel [ Time Frame: one year ]
    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.

  6. Lipoprotein composition differences-apolipoprotein [ Time Frame: one year ]
    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.

  7. Lipoprotein composition differences-NMR [ Time Frame: one year ]
    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.


Biospecimen Retention:   Samples Without DNA
Blood samples for lipids testing


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03791216


Contacts
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Contact: DermatologyCTU 312-503-5944 NUderm-research@northwestern.edu

Locations
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United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: DermatologyCTU    312-503-5944    NUderm-research@northwestern.edu   
Principal Investigator: Amy Paller, MD         
Sponsors and Collaborators
Northwestern University
National Psoriasis Foundation
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Amy Paller, MD Northwestern University

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Responsible Party: Amy Paller, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT03791216     History of Changes
Other Study ID Numbers: 2019-2361
First Posted: January 1, 2019    Key Record Dates
Last Update Posted: January 1, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases