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

Study Purpose

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.#46; a) healthy controls; and b) patients with milder psoriasis.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 6 Years - 17 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03791216
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Northwestern University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Amy Paller, MD
Principal Investigator Affiliation Northwestern University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOtherNIHOtherOther
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis
Arms & Interventions

Arms

: Psoriasis patients to be treated only topically

: Psoriasis patients with moderate-to-severe psoriasis who begin

: Age-, sex- and BMI percentile-matched controls

: Patients being treated with isotretinoin for acne

Interventions

Other: - Fasting blood draw for lipid assessments

Fasting blood draw for lipid assessments

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Chicago, Illinois

Status

Recruiting

Address

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

Chicago, Illinois, 60611

Site Contact

DermatologyCTU

[email protected]

312-503-5944

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