PsoriasisNCT00879944
Impact of the Severity of Pediatric Psoriasis on Childhood Body Mass Index
An observational study of Psoriasis and Atopic Dermatitis, run by Northwestern University at 14 sites in 6 countries.
Trial summary
The object of this research study is to examine these associations in children as very little is known about psoriasis and cardiovascular risk factors in the pediatric population. Read more about this study
- Who is it for?
- Ages 5 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis, Atopic Dermatitis
- What is being tested?
- Blood pressure, Height and Weight
- How many people
- 409 participants
- Where
- 14 sitesin 6 countries
- Study dates
- May 2009to Jul 2012
- 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 5 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 1. Children ages 5 to 17 years old with either moderate or severe plaque type psoriasis 2. Children ages 5 to 17 years old with moderate or severe atopic dermatitis 3. Children ages 5 to 17 years old seen in dermatology clinic who are healthy and without a systemic disorder.
Who may be able to join
- Subjects must be between the ages of 5 and 17 years at the time of enrollment.
- Subjects of either sex.
- Subjects who have had psoriatic plaques for more than 6 months.
- Subjects and guardians of minors must sign the approved IRB consent form(s) prior to initiation of the study protocol.
- Subjects enrolled as "non-inflammatory" normal controls will carry a common non- systemic skin condition, such as acne, nevi, warts and molluscum as their main diagnosis.
- Subjects enrolled as "inflammatory" normal controls will carry a diagnosis of moderate to severe atopic dermatitis.
Who cannot join
- Subjects who are unable to give informed consent or assent.
- Subjects who have had psoriasis for less than 6 months.
- Subjects whose condition is deemed unsafe or incapable by the study investigator for study participation.
Trial locations and contacts
14 sites in 6 countries.
14 sites in 6 countries
United States9 sites
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
University Hospitals, Case Medical Centers
Cleveland, Ohio, 44106
Texas Dermatology Associates
Dallas, Texas, 75246
Texas Children's Hospital
Houston, Texas, 77030
University of California, San Diego
San Diego, California, 92123
University of California, San Francisco
San Francisco, California, 94143
Central Dermatology
St Louis, Missouri, 63117-1206
Stanford University School of Medicine
Stanford, California, 94305
UMass Memorial Dermatology Center
Worcester, Massachusetts, 01605
About this study
Official title: Impact of the Severity of Pediatric Psoriasis on Childhood Body Mass Index and Comorbid Risk Factors: an Epidemiologic Analysis
The object of this research study is to examine these associations in children as very little is known about psoriasis and cardiovascular risk factors in the pediatric population.
Read the detailed description
Several environmental factors and comorbid conditions have been found to be associated with psoriasis in adults, including obesity, depression, smoking, and other cardiovascular risk factors such as high blood pressure. The object of this research study is to examine these associations in children as very little is known about psoriasis and cardiovascular risk factors in the pediatric population.
This is a multi-center study with a planned total enrollment of about 200 subjects ages 2-17 years old with psoriasis and 100 aged-match controls. Patient and family history will be recorded. All subjects will undergo standard height, weight, blood pressure, and waist circumference (WC). For the obese and overweight subjects we will also obtain their growth charts to attempt to correlate weight gain with psoriasis onset and progression. All data will be compiled and then statistically analyzed.
- Conditions
- Psoriasis, Atopic Dermatitis
- Being tested
- Blood pressure, Height, Weight, BMI, Waist Circumference
- Keywords
- Psoriasis, Obesity, BMI, Atopic Dermatitis
- Medical subject headings
- Psoriasis, Dermatitis, Atopic, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood pressureOther
Blood pressure will be measured once while patient is seated
HeightOther
Height will be measured in centimeters at the time of enrollment
WeightOther
Weight will be measured in kilograms at enrollment
BMIOther
Body Mass Index (BMI) will be calculated from a subject's height and weight
Waist CircumferenceOther
Waist circumference will be measured midway between the lowest rib and the superior border of the iliac crest with an inelastic measuring tape at the end of normal expiration to the nearest 0.1cm
| Study group | Role | What they receive |
|---|---|---|
| Psoriasis | Children ages 5-17 years old with moderate or severe plaque type psoriasis. Blood pressure will be measured once while patient is seated Height will be measured in centimeters at the time of enrollment Weight will be measured in kilograms at enrollment Body Mass Index (BMI) will be calculated from a subject's height and weight Waist circumference will be measured midway between the lowest rib and the superior border of the iliac crest with an inelastic measuring tape at the end of normal expiration to the nearest 0.1cm Receives: Other: Blood pressure; Other: Height; Other: Weight; Other: BMI; Other: Waist Circumference | |
| Atopic Dermatitis Controls | Children ages 5 to 17 years old with moderate to severe atopic dermatitis. Blood pressure will be measured once while patient is seated Height will be measured in centimeters at the time of enrollment Weight will be measured in kilograms at enrollment Body Mass Index (BMI) will be calculated from a subject's height and weight Waist circumference will be measured midway between the lowest rib and the superior border of the iliac crest with an inelastic measuring tape at the end of normal expiration to the nearest 0.1cm Receives: Other: Blood pressure; Other: Height; Other: Weight; Other: BMI; Other: Waist Circumference | |
| Healthy Controls | Children 5-17 years of age who are healthy and seen in dermatology clinic for a non-systemic skin condition.
Blood pressure will be measured once while patient is seated Height will be measured in centimeters at the time of enrollment Weight will be measured in kilograms at enrollment Body Mass Index (BMI) will be calculated from a subject's height and weight Waist circumference will be measured midway between the lowest rib and the superior border of the iliac crest with an inelastic measuring tape at the end of normal expiration to the nearest 0.1cm Receives: Other: Blood pressure; Other: Height; Other: Weight; Other: BMI; Other: Waist Circumference |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI
Measured: 07/2010
Secondary outcomes (2)
Blood Pressure
Measured: 07/2010
Waist circumference
Measured: 07/2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionJun 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Time perspective
- Prospective
- Enrolment
- 409 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Paller, Northwestern University
- Investigators
- Amy S Paller, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00879944
- Sponsor's protocol ID
- AP-2009-13793
- Status last verified
- Apr 2015
- First submitted
- 10 Apr 2009
- Last updated
- 14 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Paller AS, Mercy K, Kwasny MJ, Choon SE, Cordoro KM, Girolomoni G, Menter A, Tom WL, Mahoney AM, Oostveen AM, Seyger MM. Association of pediatric psoriasis severity with excess and central adiposity: an international cross-sectional study. JAMA Dermatol. 2013 Feb;149(2):166-76. doi: 10.1001/jamadermatol.2013.1078.
PubMed 23560297
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Severity of Pediatric Psoriasis on Childhood Body Mass Index and Comorbid Risk Factors: an Epidemiologic Analysis
- ClinicalTrials.gov ID
- NCT00879944
- Acronym / sponsor ID
- AP-2009-13793
- Conditions
- Psoriasis, Atopic Dermatitis
- Keywords
- Psoriasis, Obesity, BMI, Atopic Dermatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 409 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 13 Apr 2009 (estimated)
- 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.
The object of this research study is to examine these associations in children as very little is known about psoriasis and cardiovascular risk factors in the pediatric population.
Detailed description
Several environmental factors and comorbid conditions have been found to be associated with psoriasis in adults, including obesity, depression, smoking, and other cardiovascular risk factors such as high blood pressure. The object of this research study is to examine these associations in children as very little is known about psoriasis and cardiovascular risk factors in the pediatric population.
This is a multi-center study with a planned total enrollment of about 200 subjects ages 2-17 years old with psoriasis and 100 aged-match controls. Patient and family history will be recorded. All subjects will undergo standard height, weight, blood pressure, and waist circumference (WC). For the obese and overweight subjects we will also obtain their growth charts to attempt to correlate weight gain with psoriasis onset and progression. All data will be compiled and then statistically analyzed.
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Psoriasis | – | Other: Blood pressure, Other: Height, Other: Weight, Other: BMI, Other: Waist CircumferenceChildren ages 5-17 years old with moderate or severe plaque type psoriasis. Blood pressure will be measured once while patient is seated Height will be measured in centimeters at the time of enrollment Weight will be measured in kilograms at enrollment Body Mass Index (BMI) will be calculated from a subject's height and weight Waist circumference will be measured midway between the lowest rib and the superior border of the iliac crest with an inelastic measuring tape at the end of normal expiration to the nearest 0.1cm |
| Atopic Dermatitis Controls | – | Other: Blood pressure, Other: Height, Other: Weight, Other: BMI, Other: Waist CircumferenceChildren ages 5 to 17 years old with moderate to severe atopic dermatitis. Blood pressure will be measured once while patient is seated Height will be measured in centimeters at the time of enrollment Weight will be measured in kilograms at enrollment Body Mass Index (BMI) will be calculated from a subject's height and weight Waist circumference will be measured midway between the lowest rib and the superior border of the iliac crest with an inelastic measuring tape at the end of normal expiration to the nearest 0.1cm |
| Healthy Controls | – | Other: Blood pressure, Other: Height, Other: Weight, Other: BMI, Other: Waist CircumferenceChildren 5-17 years of age who are healthy and seen in dermatology clinic for a non-systemic skin condition. Blood pressure will be measured once while patient is seated Height will be measured in centimeters at the time of enrollment Weight will be measured in kilograms at enrollment Body Mass Index (BMI) will be calculated from a subject's height and weight Waist circumference will be measured midway between the lowest rib and the superior border of the iliac crest with an inelastic measuring tape at the end of normal expiration to the nearest 0.1cm |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 1. Children ages 5 to 17 years old with either moderate or severe plaque type psoriasis 2. Children ages 5 to 17 years old with moderate or severe atopic dermatitis 3. Children ages 5 to 17 years old seen in dermatology clinic who are healthy and without a systemic disorder.
Key inclusion criteria (6 listed)
- Subjects must be between the ages of 5 and 17 years at the time of enrollment.
- Subjects of either sex.
- Subjects who have had psoriatic plaques for more than 6 months.
- Subjects and guardians of minors must sign the approved IRB consent form(s) prior to initiation of the study protocol.
- Subjects enrolled as "non-inflammatory" normal controls will carry a common non- systemic skin condition, such as acne, nevi, warts and molluscum as their main diagnosis.
Key exclusion criteria (3 listed)
- Subjects who are unable to give informed consent or assent.
- Subjects who have had psoriasis for less than 6 months.
- Subjects whose condition is deemed unsafe or incapable by the study investigator for study participation.
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 |
|---|---|---|
| Blood pressureBlood pressure will be measured once while patient is seated | Other | Atopic Dermatitis Controls, Healthy Controls, Psoriasis |
| HeightHeight will be measured in centimeters at the time of enrollment | Other | Atopic Dermatitis Controls, Healthy Controls, Psoriasis |
| WeightWeight will be measured in kilograms at enrollment | Other | Atopic Dermatitis Controls, Healthy Controls, Psoriasis |
| BMIBody Mass Index (BMI) will be calculated from a subject's height and weight | Other | Atopic Dermatitis Controls, Healthy Controls, Psoriasis |
| Waist CircumferenceWaist circumference will be measured midway between the lowest rib and the superior border of the iliac crest with an inelastic measuring tape at the end of normal expiration to the nearest 0.1cm | Other | Atopic Dermatitis Controls, Healthy Controls, Psoriasis |
Primary outcome
BMI
Time frame: 07/2010
2 secondary outcomes
Blood Pressure
Time frame: 07/2010
Waist circumference
Time frame: 07/2010
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 14 Apr 2015.
- Results publication: PubMed 23560297Paller AS, Mercy K, Kwasny MJ, Choon SE, Cordoro KM, Girolomoni G, Menter A, Tom WL, Mahoney AM, Oostveen AM, Seyger MM. Association of pediatric psoriasis severity with excess and central adiposity: an international cross-sectional study. JAMA Dermatol. 2013 Feb;149(2):166-76. doi: 10.1001/jamadermatol.2013.1078.
- Northwestern University Featured Clinical Trials PageLink provided by the sponsor.
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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 S Paller, MD principal investigator
Northwestern University
14 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis and Atopic Dermatitis, run by Northwestern University at 14 sites in 6 countries.
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 6 inclusion and 3 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 14 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Canada, Chile, Hong Kong, Italy and 1 more country. 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?
BMI (time frame: 07/2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00879944, which also lists 1 linked publication.
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 14 Apr 2015.