Allergy to Arthropod StingNCT03645291
Comparison of Skin Prick Testing and Intradermal Skin Test Result of Local and Imported Insect Allergen Extracts
A study testing Local insect allergen extracts skin test in people with Allergy to Arthropod Sting, run by Mahidol University at 1 site in Thailand.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Allergy to Arthropod Sting
- What is being tested?
- Local insect allergen extracts skin test
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteThailand
- Study dates
- 20 Jun 2018to 30 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with severe insect allergy reaction
- Allow being done skin test and blood foe specific IgE
Who cannot join
- Serious systemic diseases
- severe asthma
- pregnant or nursing
- severe and extended skin lesion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- Allergy to Arthropod Sting
- Being tested
- Local insect allergen extracts skin test
- Keywords
- insect sting allergy, Hymenoptera allergy, local insect allergen extracts
- Medical subject headings
- Venom Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local insect allergen extracts skin testDiagnostic test
Also called commercial insect allergen extracts from ALK skintest
Every patient received both local and commercial insect allergen extracts but in blinded methods
| Study group | Role | What they receive |
|---|---|---|
| Skin test with local extract | Active comparator | Skin prick test and intradermal test with local stinging insect allergen extracts that develop in Immunological division of Siriraj hospital, mahidol University Receives: Diagnostic Test: Local insect allergen extracts skin test |
| Skin test with commercial extract | Sham comparator | Skin prick test and intradermal test with commercial stinging insect allergen extracts that order from ALK company Receives: Diagnostic Test: Local insect allergen extracts skin test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of positive skin test results of local and commercial insect allergen extracts
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start20 Jun 2018
- Primary completion30 May 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergy to Arthropod StingStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Comparison of skin prick testing and Intradermal skin test result of local and imported insect allergen extracts in patients with severe insect sting allergy
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nualanong Visitsunthorn, Mahidol University
- Investigators
- Nualanong Visitsunthorn, MD, Principal investigator, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03645291
- Sponsor's protocol ID
- 450/2559 (EC 3)
- Status last verified
- Aug 2019
- First submitted
- 16 Aug 2018
- Last updated
- 14 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Publication
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Skin Prick Testing and Intradermal Skin Test Result of Local and Imported Insect Allergen Extracts in Patients With Severe Insect Sting Allergy
- ClinicalTrials.gov ID
- NCT03645291
- Acronym / sponsor ID
- 450/2559 (EC 3)
- Conditions
- Allergy to Arthropod Sting
- Keywords
- insect sting allergy, Hymenoptera allergy, local insect allergen extracts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 24 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Comparison of skin prick testing and Intradermal skin test result of local and imported insect allergen extracts in patients with severe insect sting allergy
| Arm | Type | Receives |
|---|---|---|
| Skin test with local extract | Active comparator | Diagnostic Test: Local insect allergen extracts skin testSkin prick test and intradermal test with local stinging insect allergen extracts that develop in Immunological division of Siriraj hospital, mahidol University |
| Skin test with commercial extract | Sham comparator | Diagnostic Test: Local insect allergen extracts skin testSkin prick test and intradermal test with commercial stinging insect allergen extracts that order from ALK company |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with severe insect allergy reaction
- Allow being done skin test and blood foe specific IgE
Key exclusion criteria (4 listed)
- Serious systemic diseases
- severe asthma
- pregnant or nursing
- severe and extended skin lesion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Local insect allergen extracts skin testAlso: commercial insect allergen extracts from ALK skintestEvery patient received both local and commercial insect allergen extracts but in blinded methods | Diagnostic test | Skin test with commercial extract, Skin test with local extract |
Primary outcome
Comparison of positive skin test results of local and commercial insect allergen extracts
Time frame: 1 year
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Individual participant dataSharing planned: Undecided. Publication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nualanong Visitsunthorn, MD principal investigator
Siriraj Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local insect allergen extracts skin test in people with Allergy to Arthropod Sting, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of positive skin test results of local and commercial insect allergen extracts (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2019.