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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02904616

Acronym

PHOTOFLUO

Enrollment

Registered

2016-09-19

Start date

2015-01-26

Completion date

2015-02-05

Last updated

2018-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

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.

Interventions

DEVICEmobile spectrofluorimeter

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026