PsoriasisNCT03791216
Characterization of Lipoprotein Composition and Function in Pediatric Psoriasis Before and After Treatment
An observational study of Psoriasis, run by Northwestern University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- Fasting blood draw for lipid assessments
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2018to 18 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
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).
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
About this study
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.
- Conditions
- Psoriasis
- Being tested
- Fasting blood draw for lipid assessments
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasting blood draw for lipid assessmentsOther
Fasting blood draw for lipid assessments
| Study group | Role | What they receive |
|---|---|---|
| Psoriasis patients to be treated only topically | Not described Receives: Other: Fasting blood draw for lipid assessments | |
| Psoriasis patients with moderate-to-severe psoriasis who begin | Not described Receives: Other: Fasting blood draw for lipid assessments | |
| Age-, sex- and BMI percentile-matched controls | Not described Receives: Other: Fasting blood draw for lipid assessments | |
| Patients being treated with isotretinoin for acne | Not described Receives: Other: Fasting blood draw for lipid assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
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.
Measured: one year
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.
Measured: one year
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.
Measured: one year
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.
Measured: one year
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.
Measured: one year
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2019
- Study start1 Dec 2018
- Primary completion18 Jun 2025
- Study completion18 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Psoriasis Foundation, National Heart, Lung, and Blood Institute (NHLBI), Children's Hospital of Philadelphia, Radboud University Medical Center
- Responsible party
- Principal investigator, Amy Paller, Northwestern University
- Investigators
- Amy Paller, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03791216
- Sponsor's protocol ID
- 2019-2361
- Status last verified
- Jul 2025
- First submitted
- 5 Dec 2018
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Lipoprotein Composition and Function in Pediatric Psoriasis Before and After Treatment
- ClinicalTrials.gov ID
- NCT03791216
- Acronym / sponsor ID
- 2019-2361
- Conditions
- Psoriasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Psoriasis Foundation, National Heart, Lung, and Blood Institute (NHLBI), Children's Hospital of Philadelphia, Radboud University Medical Center
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 18 Jun 2025 (actual)
- Study completion
- 18 Jun 2025 (actual)
- First posted
- 2 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Psoriasis patients to be treated only topically | – | Other: Fasting blood draw for lipid assessments |
| Psoriasis patients with moderate-to-severe psoriasis who begin | – | Other: Fasting blood draw for lipid assessments |
| Age-, sex- and BMI percentile-matched controls | – | Other: Fasting blood draw for lipid assessments |
| Patients being treated with isotretinoin for acne | – | Other: Fasting blood draw for lipid assessments |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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).
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fasting blood draw for lipid assessmentsFasting blood draw for lipid assessments | Other | Age-, sex- and BMI percentile-matched controls, Patients being treated with isotretinoin for acne, Psoriasis patients to be treated only topically, Psoriasis patients with moderate-to-severe psoriasis who begin |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy Paller, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipoprotein composition differences-glucose (time frame: one year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025; AzTrials last refreshed its copy on 1 Nov 2026.