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

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Device: mobile spectrofluorimeter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy volunteers<br>Healthy volunteers wash their hands with a traditional soap. Every healthy volunteers pose with palm of hand three times on the device in order to measure basal level of fluorescence of the skin. Healthy volunteers repeated three times this procedure in order to assess the reproducibility of the measurement. | Device: mobile spectrofluorimeter<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraindividual reproducibility of measuring the natural and basal skin fluorescence | 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). | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic parameter | gender | 1 day | 
| Concomitant treatments | Concomitant treatments ( anti-inflammatory antihistaminic, antifungal...) influencing the natural and basal skin fluorescence will be listed. | 1 day | 
| Dominant hand | left hand / right hand | 1 day |