- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02764827
Comparison of Skin Prick Testing Results of Local and Imported Pollen Allergen Extracts and Specific IgE
May 6, 2016 updated by: Nualanong Visitsunthorn, Mahidol University
Comparison of Skin Prick Testing Results of Local and Imported Pollen Allergen Extracts (Bermuda ,Johnson Grasses and Careless Weed) With Specific IgE Levels.
Pollen allergen extracts are prepared locally and checked for efficacy by comparison to imported allergens and specific IgE.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Skin prick test (SPT) and specific IgE (sIgE) are approved for evaluation of allergen sensitization.
Local allergen extracts are cheaper and more available but need standardization.
Pollen allergen extracts: Bermuda, Johnson and careless weed are locally prepared and compared mean wheal diameter of skin prick test to imported allergens and also to specific IgE.
Study Type
Observational
Enrollment (Actual)
68
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
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
People 18-60 years of age who recently have positive skin prick test to grass pollen or careless weed are pricked with local and imported Bermuda grass, Johnson grass and careless weed allergen extracts.
Specific IgE levels are also measured at the same day.
Description
Inclusion Criteria:
- Positive skin prick test to Bermuda or Johnson or careless weed
Exclusion Criteria:
- Chronic diseases such as heart disease, liver, renal and severe sepsis
- Severe allergic symptoms such as anaphylaxis
- Extensive skin rashes
- Pregnancy
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
- Observational Models: Case-Crossover
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean wheal diameter of local and imported grass and weed pollens
Time Frame: 18 months
|
compare mean wheal diameter of skin prick test of different concentration among local, imported allergen extract and specific IgE levels of Bermuda grass, Johnson grass and careless weed
|
18 months
|
sIgE levels of Bermuda grass,Johnson grass and careless weed
Time Frame: 18 months
|
Measure level of sIgE of Bermuda grass,Johnson grass and careless weed and compare to SPT results
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
November 1, 2014
Primary Completion (Actual)
April 1, 2016
Study Completion (Actual)
April 1, 2016
Study Registration Dates
First Submitted
May 2, 2016
First Submitted That Met QC Criteria
May 4, 2016
First Posted (Estimate)
May 6, 2016
Study Record Updates
Last Update Posted (Estimate)
May 10, 2016
Last Update Submitted That Met QC Criteria
May 6, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Si246/2556
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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