Atopy Patch Test in Normal Population : Pilot Study

• Sponsor: Mahidol University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01156038
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arm: 1
• Duration (Months): 2.9
• Patients Per Site Per Month: 5.1

Study Details

Study Description

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 Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: N/A
• 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: Feb 1, 2010
• Actual Primary Completion Date: May 1, 2010
• Actual Study Completion Date: May 1, 2010

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Reaction of atopy patch test [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 [3 days]

   To compare outcome of atopy patch test reaction using lyophilized allergen and commercial allergen

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Department of Pediatrics, Siriraj hospital, Mahidol University	Bangkok		Thailand	10700

Sponsors and Collaborators

• Mahidol University

Investigators

• Study Director: Nualanong Visitsunthorn, Professor, Mahidol University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01156038
• Other Study ID Numbers: 599/2552(EC4)
• First Posted: Jul 2, 2010
• Last Update Posted: Jul 2, 2010
• Last Verified: Jul 1, 2010

• Keywords provided by , ,: Atopy patch test

Study Results

No Results Posted as of Jul 2, 2010