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OpenTrials
Completed

NCT Number: NCT05824637

Validation and Reproducibility of S.P.A.T. With Allergens

To improve accuracy and take out human error opportunities, Hippo Dx developed S.P.A.T., an automated skin prick test. This study will provide a comparison between manual and automated skin prick test in allergic and non-allergic individuals with a panel of common inhalant allergens.

The primary endpoint is to compare the accuracy of S.P.A.T. to detect sensitization to common aeroallergens compared to a manual skin prick test (SPT).

It is a prospective monocentric study that will include 120 study participants.

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Key information

Conditions

Allergy to House Dust Allergy Pollen Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AZ Herentals

Herentals, 2200, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adults (18-65y) with presence or absence of self-reported symptoms of inhalant allergy will be included.

Exclusion criteria

  • Skin pathology like chronic or exuberant urticaria, dermographism, chronic dermatitis that needs daily treatment
  • Use of antihistaminic medication < 7 days before the start of the study
  • Use of tricyclic antidepressants (antihistamine activity) < 7 days before the start of the study
  • Use of topical corticoids on the forearm < 7 days before the start of the study
  • Use of Omalizumab < 6 months before the start of the study
  • Pregnancy: there is a remote possibility of inducing a systemic allergic reaction that could induce uterine contractions or necessitate the use of epinephrine (thought to cause constriction of the umbilical artery)

Treatment and study plan

Skin Prick Automated Test

Device

skin prick test to detection sensitisation to aeroallergens

Skin Prick Manual Test

Diagnostic Test

skin prick test to detection sensitisation to aeroallergens

Primary outcomes

  1. Within-test agreement (% of patients with consistent results) of wheal positivity per allergen between manual and automated test.

    Time frame: 15 minutes after the diagnostic test

    Each of the allergens are pricked three times via manual and automated skin prick test. Three positive or negative test results are considered consistent whereas either one or two positive or negative test results are considered non-consistent resulting in an inconclusive test result.

Secondary outcomes

  1. Allergy symptoms assessed by visual analogue scale between patients with a positive versus negative test result.

    Time frame: day of the diagnostic test

    Visual analogue scale (0: best - 10: worse)

  2. Time (seconds) required to run an automated versus a manual skin prick test.

    Time frame: during the diagnostic test

  3. Amount of allergen solution that is required to run an automated versus a manual skin prick test.

    Time frame: during the diagnostic test

  4. Level of discomfort experienced by the patient as assessed by visual analogue scale after an automated versus a manual skin prick test.

    Time frame: 15 minutes after the diagnostic test

    Visual analogue scale (0: best - 10: worse)

Sponsors and collaborators

Lead sponsor

Hippocreates

Industry

Registry information

Official study title

Validation and Reproducibility of Type I Hypersensitivity Reaction in the Diagnostic Process of the Skin Prick Test in Allergic and Non-allergic Individuals

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 21, 2023
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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