Impact of the Severity of Pediatric Psoriasis on Childhood Body Mass Index - Full Text View

Sponsor:	Northwestern University
Information provided by (Responsible Party):	Amy Paller, Northwestern University
ClinicalTrials.gov Identifier:	NCT00879944

Purpose

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.

Condition	Intervention
Psoriasis Atopic Dermatitis	Other: Blood pressure Other: Height Other: Weight Other: BMI Other: Waist Circumference

Study Type:	Observational
Study Design:	Time Perspective: Prospective
Official Title:	Impact of the Severity of Pediatric Psoriasis on Childhood Body Mass Index and Comorbid Risk Factors: an Epidemiologic Analysis

Resource links provided by NLM:

Genetics Home Reference related topics: psoriatic arthritis

MedlinePlus related topics: Obesity Psoriasis

U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:

BMI [ Time Frame: 07/2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Blood Pressure [ Time Frame: 07/2010 ] [ Designated as safety issue: No ]
Waist circumference [ Time Frame: 07/2010 ] [ Designated as safety issue: No ]

Estimated Enrollment:	576
Study Start Date:	May 2009
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Psoriasis Children ages 5-17 years old with moderate or severe plaque type psoriasis	Other: Blood pressure Blood pressure will be measured once while patient is seated Other: Height Height will be measured in centimeters at the time of enrollment Other: Weight Weight will be measured in kilograms at enrollment Other: BMI Body Mass Index (BMI) will be calculated from a subject's height and weight Other: Waist Circumference 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 Children ages 5 to 17 years old with moderate to severe atopic dermatitis.	Other: Blood pressure Blood pressure will be measured once while patient is seated Other: Height Height will be measured in centimeters at the time of enrollment Other: Weight Weight will be measured in kilograms at enrollment Other: BMI Body Mass Index (BMI) will be calculated from a subject's height and weight Other: Waist Circumference 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 Children 5-17 years of age who are healthy and seen in dermatology clinic for a non-systemic skin condition.	Other: Blood pressure Blood pressure will be measured once while patient is seated Other: Height Height will be measured in centimeters at the time of enrollment Other: Weight Weight will be measured in kilograms at enrollment Other: BMI Body Mass Index (BMI) will be calculated from a subject's height and weight Other: Waist Circumference 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

Eligibility

Ages Eligible for Study:	5 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

Children ages 5 to 17 years old with either moderate or severe plaque type psoriasis
Children ages 5 to 17 years old with moderate or severe atopic dermatitis
Children ages 5 to 17 years old seen in dermatology clinic who are healthy and without a systemic disorder.

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00879944

Contacts

Contact: Katherine M Mercy, MD

312-227-6484

kmercy@childrensmemorial.org

Locations

United States, California
University of California, San Diego	Active, not recruiting
San Diego, California, United States, 92123
University of California, San Francisco	Active, not recruiting
San Francisco, California, United States, 94143
United States, Illinois
Children's Memorial Hospital Division of Dermatology	Recruiting
Chicago, Illinois, United States, 60614
Contact: Katherine M Mercy, MD 773-327-3326 kmercy@childrensmemorial.org
Principal Investigator: Amy S Paller, MD
Sub-Investigator: Alfred Rademaker, PhD
United States, Massachusetts
UMass Memorial Dermatology Center	Completed
Worcester, Massachusetts, United States, 01605
United States, Missouri
Central Dermatology	Completed
St. Louis, Missouri, United States, 63117-1206
United States, Ohio
University Hospitals, Case Medical Centers	Completed
Cleveland, Ohio, United States, 44106
United States, Texas
Texas Dermatology Associates	Active, not recruiting
Dallas, Texas, United States, 75246
Texas Children's Hospital	Completed
Houston, Texas, United States, 77030
Canada, Newfoundland and Labrador
Nexus Clinical Resarch	Completed
St. John's, Newfoundland and Labrador, Canada
Chile
Pontificia Universidad Catolica de Chile	Completed
Santiago, Chile
Hong Kong
University of Hong Kong	Completed
Tuen Mun, Hong Kong
Italy
Universita Verona	Completed
Verona, Italy
Netherlands
UMC St. Radboud	Completed
Nijmegen, Netherlands

Sponsors and Collaborators

Northwestern University

Investigators

Principal Investigator:

Amy S Paller, MD

Northwestern University

More Information

Additional Information:

Northwestern University Featured Clinical Trials Page This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Amy Paller, Department Chair, Northwestern University
ClinicalTrials.gov Identifier:	NCT00879944 History of Changes
Other Study ID Numbers:	AP-2009-13793
Study First Received:	April 10, 2009
Last Updated:	September 22, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Northwestern University:

Psoriasis
Obesity
BMI
Atopic Dermatitis

Additional relevant MeSH terms:

Dermatitis
Dermatitis, Atopic
Psoriasis
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn

Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on February 09, 2012