Diagnosing allergies with Skin Prick Automated Test (S.P.A.T.)

Validation and reproducibility of Type I hypersensitivity reaction in the diagnostic process of the skin prick test: Manual versus automated testing

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14098475

Enrollment

120

Registered

2022-07-18

Start date

2022-05-20

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergy diagnostics Not Applicable

Interventions

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 yea

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 e

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Aged between 18 and 65 years old

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Coefficient of variation wheal size (mm) measured using manual skin prick test (SPT) and SPAT at 15 minutes after skin prick	—

Secondary

Measure	Time frame
Number of true positive and true negative wheals using manual skin prick test (SPT) and SPAT at 15 minutes after skin prick	—

Countries

Belgium

Contacts

Public ContactLeen Cools

leen.cools@uzleuven.be+32 16 34 20 37

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026