- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02619331
Evaluation of High Speed Laser Doppler Imaging Technology (HSL-DI)
Evaluation of High Speed Laser Doppler Imaging Technology to Quantify Skin Prick Tests in Allergic Volunteers
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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Lausanne, Switzerland, 1011
- CHUV , Division of Immunology and Allergy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Atopic volunteers
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.
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Reading of allergy skin tests (in response to allergen extracts or histamine or negative control) by HSL-DI versus direct observer evaluation (CWFM)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Skin microcirculation flow changes over time (composite autcome)
Time Frame: 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.
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tests reading at 2.5 min., 5 min., 7.5 min., 10 min., 12.5 min., 15 min., 17.5 min. and 20 min.
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Collaborators and Investigators
Investigators
- Principal Investigator: François Spertini, MD, CHUV
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSL-DI
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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