Diagnosing allergies with Skin Prick Automated Test (S.P.A.T.)
| ISRCTN | ISRCTN14098475 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14098475 |
- Submission date
- 06/07/2022
- Registration date
- 18/07/2022
- Last edited
- 05/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English Summary
Background and study aims
Allergies affect 30-40% of the general population. The skin prick test is the golden standard to diagnose allergies against for example pollen, dust or food allergies. However, variable results are obtained dependent on who executes the test and on which device is used. In order to reduce this variability, an automated skin prick test device was developed and is being validated in this study.
Who can participate?
Healthy volunteers aged between 18 and 65 years old
What does the study involve?
Participants will be recruited via regular communication channels at UZ Leuven in May 2022. These individuals are asked to undergo two series of skin prick tests, one manual (arm 1) and one automated (arm 2). Both skin prick tests are performed with 9 pricks of histamine, from which a red, itchy inflamed wheal is expected on the skin, and 1 prick of glycerol control solution from which there should be no reaction.
What are the possible benefits and risks of participating?
There is no immediate personal benefit for the participants. The Risks of participating are skin itch and redness or erythema (seldom). Uticaria also known as hives, weals, welts or nettle rash, asthma attack or anaphylaxis are rare.
Where is the study run from?
University Hospital Leuven (Belgium)
When is the study starting and how long is it expected to run for?
March 2022 to May 2022
Who is funding the study?
Hippo dx (Belgium)
Who is the main contact?
1. Senne Gorris
senne@hippo-dx.com
2. Ms Leen Cools (public contact)
leen.cools@uzleuven.be
Contact information
Principal Investigator
Herestraat 49
Leuven
3000
Belgium
| Phone | +32 16 34 20 37 |
|---|---|
| peter.hellings@uzleuven.be |
Scientific
Herestraat 49
Leuven
3000
Belgium
| Phone | +32 16 34 20 37 |
|---|---|
| peter.hellings@uzleuven.be |
Public
Herestraat 49
Leuven
3000
Belgium
| Phone | +32 16 34 20 37 |
|---|---|
| leen.cools@uzleuven.be |
Scientific
Hippo Dx
Ter Heidelaan 95A
Aarschot
3200
Belgium
| senne@hippo-dx.com |
Study information
| Study design | Prospective single-centre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Validation and reproducibility of Type I hypersensitivity reaction in the diagnostic process of the skin prick test: Manual versus automated testing |
| Study hypothesis | Allergies are a major problem in global patient care, multiple methods of diagnosis have been created of which the skin prick test is the golden standard. This test, first described in the literature in 1959, has not changed over the last 60 years and is still performed manually and needs to be executed by experienced personnel. Often human error means that this test can be inaccurate and because of workload, some health care providers move to other less sensitive diagnosis methods. To improve accuracy and take out human error, Hippo Dx developed Skin Prick Automated Test (S.P.A.T.) an automated skin prick test. This study will provide a comparison between manual and automated skin prick tests. |
| Ethics approval(s) | Approved 09/05/2022, Federal Agency for Medicines and Health Products (FAHMP) of Belgium (Avenue Galilée - Galileelaan 5/03,1210, Brussels; +32 (0)2 528 44 86; annemie.zenner@fagg-afmps.be), ref: CIV-22-03-039130 |
| Condition | Allergy diagnostics |
| Intervention | Participants will be recruited via regular communication channels at UZ Leuven in May 2022. The individuals will be divided into decade age groups (i.e. sample size). Only adult subjects (18 to 65 years old) are included, this age range consists of the same population where a manual skin prick test will be performed according to international standards in skin prick testing. The participants will undergo a manual (arm 1) and an automated (arm 2) skin prick test; the automated test uses a clinical device by Hippo Dx: S.P.A.T. (skin prick automated test). Both skin prick tests are performed with 9 pricks of histamine, from which a red, itchy inflamed wheal is expected on the skin, and 1 prick of glycerol control solution from which no reaction is expected. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Not provided at time of registration |
| Primary outcome measure | Coefficient of variation wheal size (mm) measured using manual skin prick test (SPT) and SPAT at 15 minutes after skin prick |
| Secondary outcome measures | Number of true positive and true negative wheals using manual skin prick test (SPT) and SPAT at 15 minutes after skin prick |
| Overall study start date | 28/03/2022 |
| Overall study end date | 31/05/2022 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 120 |
| Total final enrolment | 118 |
| Participant inclusion criteria | Aged between 18 and 65 years old |
| Participant exclusion criteria | 1. Skin pathologies like chronic or exuberant urticaria, dermographism, and chronic dermatitis that need daily treatment 2. Use of antihistaminic medication < 7 days before the start of the study 3. Use of tricyclic antidepressants (antihistamine activity) < 7 days before the start of the study 4. Use of topical corticoids on the forearm < 7 days before the start of the study 5. Use of omalizumab < 6 months before the start of the study 6. Pregnancy |
| Recruitment start date | 20/05/2022 |
| Recruitment end date | 31/05/2022 |
Locations
Countries of recruitment
- Belgium
Study participating centre
Leuven
3000
Belgium
Sponsor information
Industry
Ter Heidelaan 95A
Aarschot
3200
Belgium
| senne@hippo-dx.com | |
| Website | https://hippo-dx.com/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 30/09/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 10/12/2022 | 02/06/2023 | Yes | No | |
| Results article | 01/11/2023 | 05/08/2024 | Yes | No |
Editorial Notes
05/08/2024: Publication reference and total final enrolment added.
02/06/2023: Publication reference added.
15/07/2022: Trial's existence confirmed by the Federal Agency for Medicines and Health Products (FAHMP) of Belgium.
