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Histamine Pharmacogenetics in Children With Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00277433
Recruitment Status : Completed
First Posted : January 16, 2006
Last Update Posted : March 20, 2017
American College of Clinical Pharmacy
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief Summary:
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 or disease Intervention/treatment
Dermatitis, Atopic Other: 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.

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Study Type : Observational
Actual Enrollment : 751 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Histamine Pharmacogenetics in Children With Atopic Dermatitis
Study Start Date : June 2004
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Histamine

Group/Cohort Intervention/treatment
Atopic Dermatitis Other: Buccal Swab
collection of buccal swab

Non-atopic control Other: Buccal Swab
collection of buccal swab

Biospecimen Retention:   Samples With DNA
buccal-derived DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00277433

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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
American College of Clinical Pharmacy
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Principal Investigator: Mary Jayne Kennedy, Pharm D. Virginia Commonwealth University
Additional Information:
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Responsible Party: Virginia Commonwealth University Identifier: NCT00277433    
Other Study ID Numbers: PPRU 10744
1U10HD045934-01 ( U.S. NIH Grant/Contract )
First Posted: January 16, 2006    Key Record Dates
Last Update Posted: March 20, 2017
Last Verified: March 2017
Keywords provided by Virginia Commonwealth University:
Atopic Dermatitis
Additional relevant MeSH terms:
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Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases