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OpenTrials
Completed

NCT Number: NCT02904616

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mobile spectrofluorimeter

Device

Primary outcomes

  1. Intraindividual reproducibility of measuring the natural and basal skin fluorescence

    Time frame: 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 outcomes

  1. Demographic parameter

    Time frame: 1 day

    gender

  2. Concomitant treatments

    Time frame: 1 day

    Concomitant treatments ( anti-inflammatory antihistaminic, antifungal...) influencing the natural and basal skin fluorescence will be listed.

  3. Dominant hand

    Time frame: 1 day

    left hand / right hand

Sponsors and collaborators

Lead sponsor

Institut de Cancérologie de Lorraine

Other

Registry information

Official study title

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

Acronym: PHOTOFLUO

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Sep 19, 2016
Registry last updated
Aug 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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