HSL-DI: Evaluation of High Speed Laser Doppler Imaging Technology

Sponsor

Centre Hospitalier Universitaire Vaudois (Other)

Overall Status

Completed

CT.gov ID

NCT02619331

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hay Fever	Procedure: Allergy test reading	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Feb 1, 2008

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Sep 1, 2011

Arms and Interventions

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.	Procedure: 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)

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.

Procedure: 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)

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHUV , Division of Immunology and Allergy	Lausanne		Switzerland	1011

Sponsors and Collaborators

Centre Hospitalier Universitaire Vaudois

Investigators

Principal Investigator: François Spertini, MD, CHUV

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

François Spertini, Associate Prof., Centre Hospitalier Universitaire Vaudois

ClinicalTrials.gov Identifier:

NCT02619331

Other Study ID Numbers:

HSL-DI

First Posted:

Dec 2, 2015

Last Update Posted:

Dec 2, 2015

Last Verified:

Nov 1, 2015

Additional relevant MeSH terms:

Rhinitis, Allergic, Seasonal

Study Results

No Results Posted as of Dec 2, 2015