Atopy Patch Test in Normal Population : Pilot Study

NCT ID: NCT01156038

Last Updated: 2010-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2010-05-31

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.

Conditions

Normal

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Atopy patch test with food allergen

Intervention Type: DEVICE

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)

Interventions

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)

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Mahidol University

Principal Investigators

Nualanong Visitsunthorn, Professor

Role: STUDY_DIRECTOR

Mahidol University

Locations

Department of Pediatrics, Siriraj hospital, Mahidol University

Bangkok, , Thailand

Countries

Thailand

Other Identifiers

599/2552(EC4)

Identifier Type: -

Identifier Source: org_study_id