Histamine Pharmacogenetics in Children With Atopic Dermatitis

March 16, 2017 updated by: Virginia Commonwealth University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

751

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 5 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Atopic Dermatitis
Other: Buccal Swab
collection of buccal swab
Non-atopic control
Other: Buccal Swab
collection of buccal swab

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
American College of Clinical Pharmacy
PPRU

Investigators

  • Principal Investigator: Mary Jayne Kennedy, Pharm D., Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

January 12, 2006

First Submitted That Met QC Criteria

January 12, 2006

First Posted (Estimate)

January 16, 2006

Study Record Updates

Last Update Posted (Actual)

March 20, 2017

Last Update Submitted That Met QC Criteria

March 16, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPRU 10744
  • 1U10HD045934-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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