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Atopy Patch Test in Normal Population : Pilot Study

This study has been completed.
Sponsor:
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT01156038
First received: May 16, 2010
Last updated: July 1, 2010
Last verified: July 2010
History of Changes

May 16, 2010
July 1, 2010
February 2010
May 2010   (final data collection date for primary outcome measure)
Reaction of atopy patch test [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
To evaluate outcome of atopy patch test reaction in non-atopic subject
Same as current
Complete list of historical versions of study NCT01156038 on ClinicalTrials.gov Archive Site
Comparisons atopy patch test reaction between lyophilized allergen and commercial allergen [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
To compare outcome of atopy patch test reaction using lyophilized allergen and commercial allergen
Same as current
Not Provided
Not Provided
 
Atopy Patch Test in Normal Population : Pilot Study
Atopy Patch Test in Normal Population : Pilot Study

Atopy patch test in normal population

The initial diagnostic work up of suspected food allergy includes patient's history, skin prick test (SPT), measurement of food specific immunoglobulin E (IgE) with serological assays, and more recently the atopy patch test. A positive SPT seems to reflect early reactions to food challenges, whereas the atopy patch test has a high diagnostic efficacy for late phase clinical reactions. The purpose of this study was to evaluate atopy patch test reaction in non-atopic population.
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Normal
Device: Atopy patch test with food allergen
Atopy patches used with food lyophilized allergen and commercial allergen were placed on back of subjects for 48 hrs then atopy patches were taken off. Subjects should return to evaluate reaction one day later(72 hrs after applying atopy patch test)
Experimental: Atopy patch test
Atopy patches were applied on healthy volunteer's back for 48 hrs then the patches were removed. Reaction was evaluated 48 and 72 hrs after applying atopy patch test
Intervention: Device: Atopy patch test with food allergen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
May 2010
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy volunteer
  • Age 18-40 yrs
  • Volunteer sign for informed consent

Exclusion Criteria:

  • who have dermographism
  • who have chronic disease eg.autoimmune disease, immune deficiency, cancer or allergic disease
  • pregnant women
  • who have severe eczema
  • who receive antihistamine, topical steroid and systemic steroid > 20 mg/day within 7 days prior study
Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT01156038
599/2552(EC4)
Yes
Mahidol University
Mahidol University
Not Provided
Study Director: Nualanong Visitsunthorn, Professor Mahidol University
Mahidol University
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP