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Evaluation of High Speed Laser Doppler Imaging Technology

Evaluation of High Speed Laser Doppler Imaging Technology to Quantify Skin Prick Tests in Allergic Volunteers

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02619331
Acronym
HSL-DI
Enrollment
50
Registered
2015-12-02
Start date
2008-02-29
Completion date
2011-09-30
Last updated
2015-12-02

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

Conditions

Hay Fever

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.

Interventions

PROCEDUREAllergy test reading

Reading of allergy skin tests (in response to allergen extracts or histamine or negative control) by HSL-DI versus direct observer evaluation (CWFM)

Sponsors

Centre Hospitalier Universitaire Vaudois
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
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.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026