Histamine Pharmacogenetics in Children With Atopic Dermatitis - Full Text View

Sponsor:	Virginia Commonwealth University
Collaborators:	ACCP PPRU Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:	Virginia Commonwealth University
ClinicalTrials.gov Identifier:	NCT00277433

Purpose

The primary goal of the study is to investigate the impact of a common genetic polymorphism in a histamine detoxification enzyme that may well have a common role in regulating the expression of atopic dermatitis (AD) and other related atopic diseases in children.

Condition	Intervention
Dermatitis, Atopic	Other: Buccal Swab

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Retrospective
Official Title:	Histamine Pharmacogenetics in Children With Atopic Dermatitis

Resource links provided by NLM:

Genetics Home Reference related topics: Help Me Understand Genetics

Drug Information available for: Histamine Histamine phosphate Histamine dihydrochloride

U.S. FDA Resources

Further study details as provided by Virginia Commonwealth University:

Biospecimen Retention: Samples With DNA

buccal-derived DNA

Enrollment:	751
Study Start Date:	June 2004
Study Completion Date:	December 2009

Groups/Cohorts	Assigned Interventions
Atopic Dermatitis	Other: Buccal Swab collection of buccal swab
Non-atopic control	Other: Buccal Swab collection of buccal swab

Detailed Description:

Atopic dermatitis (AD) is a common condition in the pediatric population, affecting an estimated 15% of all children greater than 18 months of age in the United States. It is now recognized that AD is a disease of significant heterogeneity with respect to both disease severity and response to conventional pharmacologic therapies. With the recognition of this variability comes the understanding that, as with many other allergic disease, there exist many specific disease phenotypes that ultimately govern response to pharmacologic intervention. The characterization of these unique phenotypes and their associated biologic mediators is therefore of critical therapeutic importance in the development of disease and patient-specific treatment strategies.

The long term objective of this research is to explore the effects of genetic, environmental and developmental influences on the primary determinants of histamine action in atopic children and to identify potential histamine "haplotypes" that may be predictive of disease severity, progression and/or response to therapy.

The primary hypothesis is the presence of HNMT T314 allele and /or slow acetylation genotype is associated with childhood atopic dermatitis.

Eligibility

Ages Eligible for Study:	6 Months to 5 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

Caucasian,AfricanAmerican and Hispanic children with a medical diagnosis of atopic dermatitis and healthy, age matched controls

Criteria

Inclusion Criteria:

Caucasian, Hispanic and African American children ages 6 months to 5 years with a diagnosis of atopic dermatitis within the last 12 months will constitute the candidate pool for enrollment into the study group. The diagnosis of atopic dermatitis will be determined by the presence of at least 3 major diagnostic features (i.e., pruritis, rash,relapsing-remitting presentation, family history or atopy) in addition to at least 3 minor features (including but not limited to xerosis, elevated serum IgE, ocular involvement, food allergy). Healthy Caucasian, Hispanic and African American children within the same age range will comprise the pool for enrollment into the control group.

Exclusion Criteria:

Any child with atopic dermatitis who has a documented history of asthma or bronchospasm or who is currently receiving treatment for either of these conditions will be excluded. Any control subject who has asthma or positive family history of allergy or atopic disease in a first-degree relative (biological mother, father or siblings) will also be ineligible for enrollment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00277433

Locations

United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
United States, California
University of California at San Diego
San Diego, California, United States, 92103
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Kentucky
Kosair Charities Pediatric Clinical Research Unit
Louisville, Kentucky, United States, 40202
United States, Michigan
Wayne State University/Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
United States, Texas
Baylor College of Medicine/Texas Children's Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

Virginia Commonwealth University

ACCP

PPRU

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Principal Investigator:

Mary Jayne Kennedy, Pharm D.

Virginia Commonwealth University

More Information

Additional Information:

Pediatric Pharmacology Research Unit Website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Mary Jayne Kennedy, PharmD, Virginia Commonwealth University
ClinicalTrials.gov Identifier:	NCT00277433 History of Changes
Other Study ID Numbers:	PPRU 10744, 1U10HD045934-01
Study First Received:	January 12, 2006
Last Updated:	April 28, 2010
Health Authority:	United States: Federal Government

Keywords provided by Virginia Commonwealth University:

Atopic Dermatitis
Eczema
Genetics
Histamine

Additional relevant MeSH terms:

Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

Histamine
Histamine phosphate
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 12, 2012