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

NCT00879944 | Completed DMC

• 1 other identifier: AP-2009-13793
• Study Type: observational
• Target: 409
• Locations: 6 countries
• Sites: 14

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.

Conditions

Psoriasis; Atopic Dermatitis

Keywords

Psoriasis; Obesity; BMI; Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• BMI

  07/2010

Secondary Outcomes (2)

• Blood Pressure

  07/2010

• Waist circumference

  07/2010

Study Arms (3)

Psoriasis

Children ages 5-17 years old with moderate or severe plaque type psoriasis. Blood pressure will be measured once while patient is seated Height will be measured in centimeters at the time of enrollment Weight will be measured in kilograms at enrollment Body Mass Index (BMI) will be calculated from a subject's height and weight 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

Other: Blood pressure; Other: Height; Other: Weight; Other: BMI; Other: Waist Circumference

Atopic Dermatitis Controls

Children ages 5 to 17 years old with moderate to severe atopic dermatitis. Blood pressure will be measured once while patient is seated Height will be measured in centimeters at the time of enrollment Weight will be measured in kilograms at enrollment Body Mass Index (BMI) will be calculated from a subject's height and weight 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

Other: Blood pressure; Other: Height; Other: Weight; Other: BMI; Other: Waist Circumference

Healthy Controls

Children 5-17 years of age who are healthy and seen in dermatology clinic for a non-systemic skin condition. Blood pressure will be measured once while patient is seated Height will be measured in centimeters at the time of enrollment Weight will be measured in kilograms at enrollment Body Mass Index (BMI) will be calculated from a subject's height and weight 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

Other: Blood pressure; Other: Height; Other: Weight; Other: BMI; Other: Waist Circumference

Interventions

Blood pressure OTHER

Blood pressure will be measured once while patient is seated

Atopic Dermatitis Controls; Healthy Controls; Psoriasis

Height OTHER

Height will be measured in centimeters at the time of enrollment

Atopic Dermatitis Controls; Healthy Controls; Psoriasis

Weight OTHER

Weight will be measured in kilograms at enrollment

Atopic Dermatitis Controls; Healthy Controls; Psoriasis

BMI OTHER

Body Mass Index (BMI) will be calculated from a subject's height and weight

Atopic Dermatitis Controls; Healthy Controls; Psoriasis

Waist Circumference OTHER

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; Healthy Controls; Psoriasis

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (14)

University of California, San Diego

San Diego, California, 92123, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

UMass Memorial Dermatology Center

Worcester, Massachusetts, 01605, United States

Location

Central Dermatology

St Louis, Missouri, 63117-1206, United States

Location

University Hospitals, Case Medical Centers

Cleveland, Ohio, 44106, United States

Location

Texas Dermatology Associates

Dallas, Texas, 75246, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Nexus Clinical Resarch

St. John's, Newfoundland and Labrador, Canada

Location

Pontificia Universidad Catolica de Chile

Santiago, Chile

Location

University of Hong Kong

Tuenmen, Hong Kong

Location

Universita Verona

Verona, Italy

Location

UMC St. Radboud

Nijmegen, Netherlands

Location

Related 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. 2013 Feb;149(2):166-76. doi: 10.1001/jamadermatol.2013.1078.

  PMID: 23560297 RESULT

Related Links

• Northwestern University Featured Clinical Trials Page

MeSH Terms

Conditions

Psoriasis; Dermatitis, Atopic; Obesity

Interventions

Blood Pressure; Body Height; Weights and Measures; Waist Circumference

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Body Size; Body Weights and Measures; Body Constitution; Physical Appearance, Body; Anthropometry; Investigative Techniques; Physiological Phenomena; Growth; Growth and Development

Study Officials

• Amy S Paller, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Department of Dermatology, Professor of Dermatology and Pediatric Dermatology

Study Record Dates

• First Submitted: April 10, 2009
• First Posted: April 13, 2009
• Study Start: May 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: July 1, 2012
• Last Updated: April 14, 2015

Record last verified: 2015-04

Locations

CA (1); HK (1); IT (1); US (9); CL (1); NL (1)