Atopy Patch Test in Normal Population : Pilot Study

Phase 1

Completed

• Conditions: Normal
• Interventions: Device: Atopy patch test with food allergen

• Registration Number: NCT01156038
• Lead Sponsor: Mahidol University

Brief Summary

Atopy patch test in normal population

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 Timeline

• Study Start: 2010-02
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Study First Submitted: 2010-05-16
• Status Verified: 2010-07
• Study First Submitted QC: 2010-07-01
• Last Update Submitted: 2010-07-01
• Study First Posted: 2010-07-02
• Last Update Posted: 2010-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Atopy patch test	Atopy patch test with food allergen	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

Primary Outcome Measures

Name	Time	Method
Reaction of atopy patch test	3 days	To evaluate outcome of atopy patch test reaction in non-atopic subject

Secondary Outcome Measures

Name	Time	Method
Comparisons atopy patch test reaction between lyophilized allergen and commercial allergen	3 days	To compare outcome of atopy patch test reaction using lyophilized allergen and commercial allergen

Trial Locations

Locations (1)

Department of Pediatrics, Siriraj hospital, Mahidol University; 🇹🇭 Bangkok, Thailand