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Atopy Patch Test in Normal Population : Pilot Study

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ClinicalTrials.gov Identifier: NCT01156038
Recruitment Status : Completed
First Posted : July 2, 2010
Last Update Posted : July 2, 2010
Sponsor:
Information provided by:
Mahidol University

Brief Summary:
Atopy patch test in normal population

Condition or disease Intervention/treatment Phase
Normal Device: Atopy patch test with food allergen Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Atopy Patch Test in Normal Population : Pilot Study
Study Start Date : February 2010
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Arm Intervention/treatment
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)




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


Secondary Outcome Measures :
  1. 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



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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

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

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

Keywords provided by Mahidol University:
Atopy patch test