NCT01156038

Brief Summary

Atopy patch test in normal population

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2010

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 2, 2010

Completed
Last Updated

July 2, 2010

Status Verified

July 1, 2010

Enrollment Period

3 months

First QC Date

May 16, 2010

Last Update Submit

July 1, 2010

Conditions

Normal

Keywords

Atopy patch test

Outcome Measures

Primary Outcomes (1)

  • Reaction of atopy patch test

    To evaluate outcome of atopy patch test reaction in non-atopic subject

    3 days

Secondary Outcomes (1)

  • Comparisons atopy patch test reaction between lyophilized allergen and commercial allergen

    3 days

Study Arms (1)

Atopy patch test

EXPERIMENTAL

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

Interventions

Atopy patch test with food allergenDEVICE

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)

Atopy patch test

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteer
  • Age 18-40 yrs
  • Volunteer sign for informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pediatrics, Siriraj hospital, Mahidol University

Bangkok, 10700, Thailand

Location

Study Officials

  • Nualanong Visitsunthorn, Professor

    Mahidol University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 16, 2010

First Posted

July 2, 2010

Study Start

February 1, 2010

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

July 2, 2010

Record last verified: 2010-07

Locations

TH(1)