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

Not Applicable

Completed

• Conditions: Healthy Volunteers
• Interventions: Device: mobile spectrofluorimeter

• Registration Number: NCT02904616
• Lead Sponsor: Institut de Cancérologie de Lorraine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-26
• Primary Completion: 2015-02-05
• Study Completion: 2015-02-05
• Study First Submitted: 2016-09-02
• Study First Submitted QC: 2016-09-13
• Study First Posted: 2016-09-19
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-07
• Last Update Posted: 2018-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy volunteers	mobile spectrofluorimeter	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.

Primary Outcome Measures

Name	Time	Method
Intraindividual reproducibility of measuring the natural and basal skin fluorescence	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).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Institut de Cancérologie de Lorraine; 🇫🇷 Vandoeuvre-lès-Nancy, France