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Atopy Patch Test in Normal Population : Pilot Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01156038
First Posted: July 2, 2010
Last Update Posted: July 2, 2010
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.
Information provided by:
Mahidol University
  Purpose
Atopy patch test in normal population

Condition Intervention Phase
Normal Device: Atopy patch test with food allergen Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Atopy Patch Test in Normal Population : Pilot Study

Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • Reaction of atopy patch test [ Time Frame: 3 days ]
    To evaluate outcome of atopy patch test reaction in non-atopic subject


Secondary Outcome Measures:
  • Comparisons atopy patch test reaction between lyophilized allergen and commercial allergen [ Time Frame: 3 days ]
    To compare outcome of atopy patch test reaction using lyophilized allergen and commercial allergen


Enrollment: 15
Study Start Date: February 2010
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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)

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01156038


Locations
Thailand
Department of Pediatrics, Siriraj hospital, Mahidol University
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
Study Director: Nualanong Visitsunthorn, Professor Mahidol University
  More Information

Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT01156038     History of Changes
Other Study ID Numbers: 599/2552(EC4)
First Submitted: May 16, 2010
First Posted: July 2, 2010
Last Update Posted: July 2, 2010
Last Verified: July 2010

Keywords provided by Mahidol University:
Atopy patch test