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Clinical Trials/NCT00879944
NCT00879944
Completed
N/A

Impact of the Severity of Pediatric Psoriasis on Childhood Body Mass Index and Comorbid Risk Factors: an Epidemiologic Analysis

Northwestern University14 sites in 6 countries409 target enrollmentMay 2009

Overview

Phase
N/A
Intervention
Not specified
Conditions
Psoriasis
Sponsor
Northwestern University
Enrollment
409
Locations
14
Primary Endpoint
BMI
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2009
End Date
July 2012
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Amy Paller

Chair, Department of Dermatology, Professor of Dermatology and Pediatric Dermatology

Northwestern University

Eligibility 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.

Outcomes

Primary Outcomes

BMI

Time Frame: 07/2010

Secondary Outcomes

  • Waist circumference(07/2010)
  • Blood Pressure(07/2010)

Study Sites (14)

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