Impact of the Severity of Pediatric Psoriasis on Childhood Body Mass Index

This study is currently recruiting participants.
Verified February 2014 by Northwestern University
Sponsor:
Information provided by (Responsible Party):
Amy Paller, Northwestern University
ClinicalTrials.gov Identifier:
NCT00879944
First received: April 10, 2009
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

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.


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:


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 2015
Estimated Primary Completion Date: June 2015 (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

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.

  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
  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.
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: Gil Abramovici, MD 312-227-6484 gabramovici@luriechildrens.org

Locations
United States, California
University of California, San Diego Recruiting
San Diego, California, United States, 92123
Contact: Wynnis Tom, MD         
Principal Investigator: Wynnis Tom, MD         
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Kelly M Cordoro, MD    415-885-7800    cordorok@derm.ucsf.edu   
Principal Investigator: Kelly M Cordoro, MD         
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Latanya J Benjamin, MD    650-725-9051    Dr.Benjamin@stanford.edu   
Principal Investigator: Latanya J Benjamin, MD         
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 Recruiting
Dallas, Texas, United States, 75246
Contact: Alan Menter, MD    214-820-9114    amderm@gmail.com   
Principal Investigator: Alan Menter, MD         
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:
No publications provided by Northwestern University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amy Paller, Chair, Department of Dermatology, Professor of Dermatology and Pediatric Dermatology, Northwestern University
ClinicalTrials.gov Identifier: NCT00879944     History of Changes
Other Study ID Numbers: AP-2009-13793
Study First Received: April 10, 2009
Last Updated: February 20, 2014
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 April 22, 2014