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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-26

Study Completion Date

2015-02-05

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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

mobile spectrofluorimeter

Intervention Type DEVICE

Interventions

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mobile spectrofluorimeter

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No