- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03645291
Comparison of Skin Prick Testing and Intradermal Skin Test Result of Local and Imported Insect Allergen Extracts
August 12, 2019 updated by: Nualanong Visitsunthorn, Mahidol University
Comparison of Skin Prick Testing and Intradermal Skin Test Result of Local and Imported Insect Allergen Extracts in Patients With Severe Insect Sting Allergy
Comparison the results of skin prick testing and Intradermal skin test result of local and imported insect allergen extracts in patients with serious insect sting allergy reactions
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The patients with serious insect sting allergy reactions were evaluated and skin prick test and intradermal test with local and imported insect allergen extracts were performed.
Specific IgE for insects was also performed.
The results of skin prick testing and Intradermal skin test of local and imported insect allergen extracts were compared.
The results also compared with specific IgE to insects
Study Type
Interventional
Enrollment (Actual)
27
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Bangkok, Thailand, 10700
- Siriraj Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with severe insect allergy reaction
- Allow being done skin test and blood foe specific IgE
Exclusion Criteria:
- Serious systemic diseases
- severe asthma
- pregnant or nursing
- severe and extended skin lesion
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Skin test with local extract
Skin prick test and intradermal test with local stinging insect allergen extracts that develop in Immunological division of Siriraj hospital, mahidol University
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Every patient received both local and commercial insect allergen extracts but in blinded methods
Other Names:
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Sham Comparator: Skin test with commercial extract
Skin prick test and intradermal test with commercial stinging insect allergen extracts that order from ALK company
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Every patient received both local and commercial insect allergen extracts but in blinded methods
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of positive skin test results of local and commercial insect allergen extracts
Time Frame: 1 year
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Measure wheal size of skin test of local and commercial insect allergen extracts then compare the positive result and wheal size between local and commercial extracts.
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1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nualanong Visitsunthorn, MD, Siriraj Hospital, Mahidol University, Bangkok, Thailand.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 20, 2018
Primary Completion (Actual)
May 30, 2019
Study Completion (Actual)
July 30, 2019
Study Registration Dates
First Submitted
August 16, 2018
First Submitted That Met QC Criteria
August 22, 2018
First Posted (Actual)
August 24, 2018
Study Record Updates
Last Update Posted (Actual)
August 14, 2019
Last Update Submitted That Met QC Criteria
August 12, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 450/2559 (EC 3)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
IPD Plan Description
Publication
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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