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

Institut de Cancérologie de Lorraine

Status: Completed

Conditions: Healthy Volunteers

Treatments: Device: mobile spectrofluorimeter

Study type: Interventional

Funder types: Other

Identifiers

NCT02904616

2014-A01220-47

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Healthy volunteers

Experimental group

Description:

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.

Treatment:

Device: mobile spectrofluorimeter