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

NCT02904616 | Completed

• 1 other identifier: 2014-A01220-47
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Demographic parameter

  1 day

• Concomitant treatments

  1 day

• Dominant hand

  1 day

Study Arms (1)

Healthy volunteers

EXPERIMENTAL

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

Interventions

mobile spectrofluorimeter DEVICE

Healthy volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut de Cancérologie de Lorraine: lead

Study Sites (1)

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54500, France

Location

Study Officials

• Guillemin François, MD, PUPH

  Institut de Cancérologie de Lorraine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2016
• First Posted: September 19, 2016
• Study Start: January 26, 2015
• Primary Completion: February 5, 2015
• Study Completion: February 5, 2015
• Last Updated: August 8, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)