Validation of a Medical Device, a Mobile Spectrofluorimeter, Measuring Skin Autofluorescence in Healthy Volunteers

Institut de Cancérologie de Lorraine1 site in 1 country32 target enrollmentJanuary 26, 2015

ConditionsHealthy Volunteers

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Healthy Volunteers
Sponsor: Institut de Cancérologie de Lorraine
Enrollment: 32
Locations: 1
Primary Endpoint: Intraindividual reproducibility of measuring the natural and basal skin fluorescence
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The Institut has developed a spectrofluorimeter for the registration and monitoring of skin autofluorescence.

This Spectrofluorometer must be initially validated in healthy volunteers. In the long term, it will be used clinically to measure residual photosensitivity of patients who received a photosensitizer in photodynamic therapy.

Registry

clinicaltrials.gov

Start Date

January 26, 2015

End Date

February 5, 2015

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Institut de Cancérologie de Lorraine

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Man and woman over 18 yers old
•Women of childbearing age under contraceptive
•Healthy volunteers able and willing to follow all procedures of the agreement with the study protocol.
•Healthy volunteers affiliated to the social security
•Ability to provide written informed consent
•Patient's legal capacity to consent to study participation

Exclusion Criteria

•Healthy volunteers with scars or open wounds on the palms
•Healthy volunteers with warts on their hands
•Healthy volunteers with blister on their hands
•Healthy volunteers involved in another clinical trial
•Pregnant or breastfeeding women
•People in emergencies
•Deprived of liberty or under supervision

Outcomes

Primary Outcomes

Intraindividual reproducibility of measuring the natural and basal skin fluorescence

Time Frame: 1 day

The intra-individual reproducibility of measurement of natural and basal skin fluorescence will be evaluated on a healthy volunteers using a mobile spectrofluorimeter. The value of intra-class correlation coefficient will be measured by the method of Fleiss (Fleiss, 1986).