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
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT01156038     History of Changes
Other Study ID Numbers: 599/2552(EC4)
Study First Received: May 16, 2010
Last Updated: July 1, 2010
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
Atopy patch test

ClinicalTrials.gov processed this record on October 23, 2014