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CompletedNCT00277433Updated Mar 20, 2017

Histamine Pharmacogenetics in Children With Atopic Dermatitis

An observational study in Dermatitis, Atopic, sponsored by Virginia Commonwealth University. Completed at 7 sites in United States. Open to participants aged 6 Months to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-20.

Sponsored by Virginia Commonwealth University · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
751
Ages
6 Months to 5 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Dermatitis, Atopic

Keywords

  • Atopic Dermatitis
  • Eczema
  • Genetics
  • Histamine
03

In context

Dermatitis, Atopic

1,443 studies on the registry are indexed under Dermatitis, Atopic; 253 are open to participants now.

This study's enrollment of 751 is above the median of 150 across 241 observational studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Virginia Commonwealth University is the lead sponsor of 648 studies on the registry; 82 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 64 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 5 Years
Sexes eligible
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
751 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • Atopic Dermatitis

    Other: Buccal Swab

  • Non-atopic control

    Other: Buccal Swab

Interventions

  • OtherBuccal Swab

    collection of buccal swab

06

Study locations

7 sites
  • Arkansas Children's Hospital
    Little Rock, Arkansas 72202, United States
  • University of California at San Diego
    San Diego, California 92103, United States
  • Children's National Medical Center
    Washington D.C., District of Columbia 20010, United States
  • Kosair Charities Pediatric Clinical Research Unit
    Louisville, Kentucky 40202, United States
  • Wayne State University/Children's Hospital of Michigan
    Detroit, Michigan 48201, United States
  • Children's Mercy Hospital
    Kansas City, Missouri 64108, United States
  • Baylor College of Medicine/Texas Children's Cancer Center
    Houston, Texas 77030, United States
07

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2004, a primary completion of Dec 2009 and a completion of Dec 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 12, 2006
First posted
Jan 16, 2006
Start
Jun 2004
Primary completionActual
Dec 2009
CompletionActual
Dec 2009
Last update
Mar 20, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 20, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00277433
Collaborators
American College of Clinical Pharmacy, PPRU, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Responsible party
Sponsor
First posted
Jan 16, 2006
Start date
Jun 2004
Primary completion
Dec 2009
Completion
Dec 2009
Last update
Mar 20, 2017

Study contacts

Mary Jayne Kennedy, Pharm D.
principal investigator · Virginia Commonwealth University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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