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

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00879944
• Other study ID #: AP-2009-13793
• Status: Completed
• Phase: N/A
• First received: April 10, 2009
• Last updated: April 10, 2015
• Start date: May 2009
• Est. completion date: July 2012

Study information

• Verified date: April 2015
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 409
• Est. completion date: July 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 17 Years

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Psoriasis

Intervention

Other:
• Blood pressure
Blood pressure will be measured once while patient is seated
• Height
Height will be measured in centimeters at the time of enrollment
• Weight
Weight will be measured in kilograms at enrollment
• BMI
Body Mass Index (BMI) will be calculated from a subject's height and weight
• 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

Locations

Country	Name	City	State
Canada	Nexus Clinical Resarch	St. John's	Newfoundland and Labrador
Chile	Pontificia Universidad Catolica de Chile	Santiago
Hong Kong	University of Hong Kong	Tuen Mun
Italy	Universita Verona	Verona
Netherlands	UMC St. Radboud	Nijmegen
United States	Ann & Robert H Lurie Children's Hospital of Chicago	Chicago	Illinois
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	University of California, San Diego	San Diego	California
United States	University of California, San Francisco	San Francisco	California
United States	Central Dermatology	St. Louis	Missouri
United States	Stanford University School of Medicine	Stanford	California
United States	UMass Memorial Dermatology Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Countries where clinical trial is conducted

United States,  Canada,  Chile,  Hong Kong,  Italy,  Netherlands, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI		07/2010	No
Secondary	Blood Pressure		07/2010	No
Secondary	Waist circumference		07/2010	No

External Links

•   Northwestern University Featured Clinical Trials Page