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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Device: mobile spectrofluorimeter

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Vandoeuvre-lès-Nancy, France, 54500
    • Institut de Cancerologie de Lorraine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy volunteers; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Institut de Cancérologie de Lorraine
• Investigators: Principal Investigator: Guillemin François, MD, PUPH, Institut de Cancerologie de Lorraine

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2015
• Primary Completion (Actual): February 5, 2015
• Study Completion (Actual): February 5, 2015

Study Registration Dates

• First Submitted: September 2, 2016
• First Submitted That Met QC Criteria: September 13, 2016
• First Posted (Estimate): September 19, 2016

Study Record Updates

• Last Update Posted (Actual): August 8, 2018
• Last Update Submitted That Met QC Criteria: August 7, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 2014-A01220-47

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO