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

Completed

• Conditions: Atopic Dermatitis; Psoriasis

• Registration Number: NCT00879944
• Lead Sponsor: Northwestern University

Brief 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.

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 Timeline

• Study First Submitted: 2009-04-10
• Study First Submitted QC: 2009-04-10
• Study First Posted: 2009-04-13
• Study Start: 2009-05
• Primary Completion: 2012-06
• Study Completion: 2012-07
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-10
• Last Update Posted: 2015-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 409

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
BMI	07/2010

Secondary Outcome Measures

Name	Time	Method
Waist circumference	07/2010
Blood Pressure	07/2010

Trial Locations

Locations (14)

University of California, San Diego; 🇺🇸 San Diego, California, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States

Ann & Robert H Lurie Children's Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States

UMass Memorial Dermatology Center; 🇺🇸 Worcester, Massachusetts, United States

Central Dermatology; 🇺🇸 St. Louis, Missouri, United States

University Hospitals, Case Medical Centers; 🇺🇸 Cleveland, Ohio, United States

Texas Dermatology Associates; 🇺🇸 Dallas, Texas, United States

Texas Children's Hospital; 🇺🇸 Houston, Texas, United States

Nexus Clinical Resarch; 🇨🇦 St. John's, Newfoundland and Labrador, Canada

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