Histamine Pharmacogenetics in Children With Atopic Dermatitis

This study is currently recruiting participants.

Verified by Virginia Commonwealth University, July 2009

First Received: January 12, 2006 Last Updated: July 7, 2009 History of Changes

Sponsor:	Virginia Commonwealth University
Collaborators:	American College of Clinical Pharmacy Pediatric Pharmacology Research Unit (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:	Case Control, Retrospective
Official Title:	Histamine Pharmacogenetics in Children With Atopic Dermatitis

Resource links provided by NLM:

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

Biospecimen Description:

buccal-derived DNA

Estimated Enrollment:	720
Study Start Date:	June 2004
Estimated Study Completion Date:	December 2009

Groups/Cohorts	Assigned Interventions
1	Other: Buccal Swab collection of buccal swab
2	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	Recruiting
Little Rock, Arkansas, United States, 72202
Contact: Kim Stuckey, RNP 501-824-4209
United States, California
University of California at San Diego	Not yet recruiting
San Diego, California, United States, 92103
Contact: Rosalinda Cruz 619-497-2182 rocruz@ucsd.edu
United States, District of Columbia
Children's National Medical Center	Completed
Washington, District of Columbia, United States, 20010
United States, Kentucky
Kosair Charities Pediatric Clinical Research Unit	Completed
Louisville, Kentucky, United States, 40202
United States, Michigan
Wayne State University/Children's Hospital of Michigan	Active, not recruiting
Detroit, Michigan, United States, 48201
United States, Missouri
Children's Mercy Hospital	Recruiting
Kansas City, Missouri, United States, 64108
Contact: Gregory Kearns, Pharm.D. 816-234-3059
United States, Texas
Baylor College of Medicine/Texas Children's Cancer Center	Recruiting
Houston, Texas, United States, 77030
Contact: Karen Jones, RN 832-824-4209

Sponsors and Collaborators

Virginia Commonwealth University

American College of Clinical Pharmacy

Pediatric Pharmacology Research Unit (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:	Virginia Commonwealth University ( Mary Jayne Kennedy, PharmD )
Study ID Numbers:	PPRU 10744
Study First Received:	January 12, 2006
Last Updated:	July 7, 2009
ClinicalTrials.gov Identifier:	NCT00277433 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Virginia Commonwealth University:

Atopic Dermatitis
Eczema
Genetics
Histamine

Additional relevant MeSH terms:

Neurotransmitter Agents
Dermatitis, Atopic
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Immune System Diseases
Physiological Effects of Drugs
Histamine Agents
Pharmacologic Actions
Histamine

Hypersensitivity
Genetic Diseases, Inborn
Histamine Agonists
Hypersensitivity, Immediate
Skin Diseases, Eczematous
Histamine phosphate
Skin Diseases, Genetic
Dermatitis

ClinicalTrials.gov processed this record on November 27, 2009