Atopy Patch Test in Normal Population : Pilot Study

Normal Clinical Trial

Official title:

Atopy Patch Test in Normal Population : Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01156038
• Other study ID #: 599/2552(EC4)
• Status: Completed
• Phase: Phase 1
• First received: May 16, 2010
• Last updated: July 1, 2010
• Start date: February 2010
• Est. completion date: May 2010

Study information

• Verified date: July 2010
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

Atopy patch test in normal population

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Normal

Intervention

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)

Locations

Country	Name	City	State
Thailand	Department of Pediatrics, Siriraj hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reaction of atopy patch test	To evaluate outcome of atopy patch test reaction in non-atopic subject	3 days	Yes
Secondary	Comparisons atopy patch test reaction between lyophilized allergen and commercial allergen	To compare outcome of atopy patch test reaction using lyophilized allergen and commercial allergen	3 days	Yes