Evaluation of High Speed Laser Doppler Imaging Technology
- Conditions
- Hay Fever
- Registration Number
- NCT02619331
- Lead Sponsor
- Centre Hospitalier Universitaire Vaudois
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- age 18 to 65 years
- history of allergic rhinitis to birch pollen and/or grass pollen.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Skin microcirculation flow changes over time (composite autcome) tests reading at 2.5 min., 5 min., 7.5 min., 10 min., 12.5 min., 15 min., 17.5 min. and 20 min. Skin microcirculation flow changes will be evaluated at 2.5 min., 5 min., 7.5 min., 10 min., 12.5 min., 15 min., 17.5 min. and 20 min. as measured in a composite outcome 1) by HS-LDI based on parameter "area" corresponding to the total number of non-zero pixels in the flare area and parameter "flow" as measured according to a specific formula in arbitrary units, or 2) as measured by conventional wheal and flare measurement (CWFM, direct observer reading) in mm.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CHUV , Division of Immunology and Allergy
🇨🇭Lausanne, Switzerland
CHUV , Division of Immunology and Allergy🇨🇭Lausanne, Switzerland