Evaluation of High Speed Laser Doppler Imaging Technology

NCT ID: NCT02619331

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2011-09-30

Brief Summary

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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

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Conditions

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Hay Fever

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Allergy test reading

Intervention Type PROCEDURE

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

Interventions

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Allergy 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)

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role lead

Responsible Party

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François Spertini

Associate Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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François Spertini, MD

Role: PRINCIPAL_INVESTIGATOR

CHUV

Locations

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CHUV , Division of Immunology and Allergy

Lausanne, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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HSL-DI

Identifier Type: -

Identifier Source: org_study_id