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Histamine Pharmacogenetics in Children With Atopic Dermatitis

6 Months
5 Years
Not Enrolling
Dermatitis, Atopic

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Trial Information

Histamine Pharmacogenetics in Children With Atopic Dermatitis

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.

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.

Type of Study:


Study Design:

Observational Model: Case Control, Time Perspective: Retrospective

Principal Investigator

Mary Jayne Kennedy, Pharm D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Virginia Commonwealth University


United States: Federal Government

Study ID:

PPRU 10744



Start Date:

June 2004

Completion Date:

December 2009

Related Keywords:

  • Dermatitis, Atopic
  • Atopic Dermatitis
  • Eczema
  • Genetics
  • Histamine
  • Dermatitis
  • Dermatitis, Atopic



Children's National Medical Center Washington, District of Columbia  20010-2970
Children's Mercy Hospital Kansas City, Missouri  64108
Arkansas Children's Hospital Little Rock, Arkansas  72202-3591
University of California at San Diego La Jolla, California  92093
Kosair Charities Pediatric Clinical Research Unit Louisville, Kentucky  40202
Wayne State University/Children's Hospital of Michigan Detroit, Michigan  48201
Baylor College of Medicine/Texas Children's Cancer Center Houston, Texas  77030