Evaluation of High Speed Laser Doppler Imaging Technology

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.

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Key information

Conditions

Hay Fever 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

CHUV , Division of Immunology and Allergy

Lausanne, 1011, Switzerland

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Allergy test reading

Procedure

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

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Registry information

Official study title

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

Acronym: HSL-DI

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2011
First posted: Dec 2, 2015
Registry last updated: Dec 2, 2015

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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Completed