Clinical trial NCT00879944: Impact of the Severity of Pediatric Psoriasis on Childhood Body Mass Index
Official title: Impact of the Severity of Pediatric Psoriasis on Childhood Body Mass Index and Comorbid Risk Factors: an Epidemiologic Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Atopic Dermatitis
Keywords: Psoriasis
Obesity
BMI
Atopic Dermatitis
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2009-04-13
Enrollment: 409
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: BMI
timeFrame: 07/2010
Secondary outcomes:
measure: Blood Pressure
timeFrame: 07/2010
measure: Waist circumference
timeFrame: 07/2010
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Chicago
country: United States
facility: Ann & Robert H Lurie Children's Hospital of Chicago
state: Illinois
city: Worcester
country: United States
facility: UMass Memorial Dermatology Center
state: Massachusetts
city: St. Louis
country: United States
facility: Central Dermatology
state: Missouri
city: Cleveland
country: United States
facility: University Hospitals, Case Medical Centers
state: Ohio
city: Dallas
country: United States
facility: Texas Dermatology Associates
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: St. John's
country: Canada
facility: Nexus Clinical Resarch
state: Newfoundland and Labrador
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile
city: Tuen Mun
country: Hong Kong
facility: University of Hong Kong
city: Verona
country: Italy
facility: Universita Verona
city: Nijmegen
country: Netherlands
facility: UMC St. Radboud
Study officials:
affiliation: Northwestern University
name: Amy S Paller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. 2013 Feb;149(2):166-76. doi: 10.1001/jamadermatol.2013.1078.