Evaluation of High Speed Laser Doppler Imaging Technology (HSL-DI)

Vaud University Hospital Center

Status: Completed

Conditions: Hay Fever

Treatments: Procedure: Allergy test reading

Study type: Interventional

Funder types: Other

Identifiers

NCT02619331

HSL-DI

Details and patient eligibility

About

Skin prick tests (SPT) are commonly used in daily allergological practice to assess skin reactivity to allergens. Multiple factors can contribute to non-optimal results of conventional wheal and flare measurement (CWFM) of SPT such as inaccurate measurements, observer-dependency and absence of traceability.

This study aims to evaluate the quantification of SPT by a novel High Speed Laser Doppler Imaging (HSL-DI) and to compare it with CWFM. First, SPT with birch and/or grass pollen extracts as well as positive and negative controls will be performed in 20 volunteers (11 atopics, 9 non-atopics) to establish the characteristics (cut-off, optimal reading time and allergen concentration) of HSL-DI analysis based on two parameters ("area" and "flow" measurement). In a second step, fifty patients will be tested with birch and grass pollen extracts at optimal allergen concentration and time window. Analysis of SPT by HSL-DI and CWFM will be compared.

Enrollment: 50 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• age 18 to 65 years
• history of allergic rhinitis to birch pollen and/or grass pollen.

Exclusion criteria

• any medical condition (including pregnancy) that could influence the study (viral or bacterial airway infection, active allergic rhinitis)
• uncontrolled asthma (peak expiratory "flow" <80% of volunteer's best personal value)
• treatment with antihistamine medication less than two weeks before enrolment or during the trial.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Atopic volunteers

Experimental group

Description:

Allergy tests will be performed in allergic patients with rhinoconjunctivitis and allergy test reading measured following two different methodologies. 1) test reading based on conventional wheal and flare measurement (wheal diameter in mm, CWFM), 2) test reading based on high speed laser doppler imaging (HS-LDI). Both type of tests reading will be compared.

Treatment:

Procedure: Allergy test reading