- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04013763
Outcome of Specific IgE Level in Children With IgE-mediated Wheat Allergy After Stop Using Wheat Containing Skin Care
April 7, 2022 updated by: Mahidol University
Wheat allergy is increasing in Thailand.
Some studies show that cutaneous exposure of allergen may cause allergy and there are many wheat containing skin care products that are over-the-counter.
So the purpose of our study is to determine level of specific immunoglobulin E antibodies to wheat and omega-5 gliadin in wheat allergy patients after stop using wheat containing skin care products.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
All children in this study were sensitized to wheat.
Each patient was clinically evaluated, with focus on wheat allergy by medical history, medical examination included skin status (suspected atopic dermatitis or not).
Blood sample was taken for baseline determination of immunoglobulin E antibodies to wheat and to omega-5 gliadin.
Transepidermal water loss was examined in case with atopic dermatitis.
The primary outcome was the specific immunoglobulin E antibodies to wheat and omega-5 gliadin in case that stop using wheat containing skin care product and case that continue using products.
Study Type
Interventional
Enrollment (Actual)
7
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
-
-
Bangkok
-
Bangkok noi, Bangkok, Thailand, 10700
- Siriraj Hospital
-
-
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
1 year to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- children age 1 to 18 years
- History of IgE-mediated wheat allergy
Exclusion Criteria:
- Parents refused to sign the consent
- severe atopic dermatitis
- on oral immunothery
- severe IgE mediated reaction after using wheat containing skin care product
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Atopic dermatitis with stop using product
case wheat allergy with atopic dermatitis and stop using wheat containing skin care products
|
stop or continue using wheat containing skin care products
|
Experimental: Atopic dermatitis with containing using product
case wheat allergy with atopic dermatitis and continue using wheat containing skin care products
|
stop or continue using wheat containing skin care products
|
Experimental: Non atopic dermatitis with stop using product
case wheat allergy with normal skin and stop using wheat containing skin care products
|
stop or continue using wheat containing skin care products
|
Experimental: Non atopic dermatitis with continue using product
case wheat allergy with normal skin and continue using wheat containing skin care products
|
stop or continue using wheat containing skin care products
|
No Intervention: Atopic dermatitis with no product use
case wheat allergy who does not use wheat containing skin care products and has atopic dermatitis
|
|
No Intervention: Non atopic dermatitis with no product use
case wheat allergy who does not use wheat containing skin care products and no atopic dermatitis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Specific IgE to wheat and omega-5 gliadin level
Time Frame: 1 year
|
To follow-up the level of wheat and omega5 gliadin specificIgE after stop using the wheat containing skin care product compare to patients who continue using the product.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
level of transepidermal water loss
Time Frame: 1 year
|
To follow up the transepidermal water loss in patients with atopic dermatitis, comparing the group that continue using the product to the group that stop using the product.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
July 1, 2019
Primary Completion (Actual)
August 31, 2020
Study Completion (Actual)
August 31, 2020
Study Registration Dates
First Submitted
July 1, 2019
First Submitted That Met QC Criteria
July 8, 2019
First Posted (Actual)
July 10, 2019
Study Record Updates
Last Update Posted (Actual)
April 8, 2022
Last Update Submitted That Met QC Criteria
April 7, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 038/2562(EC1)
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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