Healthy VolunteersPHOTOFLUONCT02904616
Validation of a Medical Device, a Mobile Spectrofluorimeter, Measuring Skin Autofluorescence in Healthy Volunteers.
A study testing mobile spectrofluorimeter in people with Healthy Volunteers, run by Institut de Cancérologie de Lorraine at 1 site in France.
Trial summary
The Institut has developed a spectrofluorimeter for the registration and monitoring of skin autofluorescence. This Spectrofluorometer must be initially validated in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- mobile spectrofluorimeter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jan 2015to 5 Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy Volunteers
- Being tested
- mobile spectrofluorimeter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile spectrofluorimeterDevice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: mobile spectrofluorimeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 day
Secondary outcomes (3)
Demographic parameter
gender
Measured: 1 day
Concomitant treatments
Concomitant treatments ( anti-inflammatory antihistaminic, antifungal...) influencing the natural and basal skin fluorescence will be listed.
Measured: 1 day
Dominant hand
left hand / right hand
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study start26 Jan 2015
- Primary completion5 Feb 2015
- Study completion5 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de Lorraine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillemin François, MD, PUPH, Principal investigator, Institut de Cancérologie de Lorraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02904616
- Sponsor's protocol ID
- 2014-A01220-47
- Acronym
- PHOTOFLUO
- Status last verified
- Aug 2018
- First submitted
- 2 Sep 2016
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Medical Device, a Mobile Spectrofluorimeter, Measuring Skin Autofluorescence in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02904616
- Acronym / sponsor ID
- PHOTOFLUO / 2014-A01220-47
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Institut de Cancérologie de LorraineUniversity, hospital or other
- Study start
- 26 Jan 2015 (actual)
- Primary completion
- 5 Feb 2015 (actual)
- Study completion
- 5 Feb 2015 (actual)
- First posted
- 19 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Experimental | Device: mobile spectrofluorimeterHealthy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mobile spectrofluorimeter | Device | Healthy volunteers |
Primary outcome
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).
3 secondary outcomes
Demographic parameter
Time frame: 1 day
Concomitant treatments
Time frame: 1 day
Dominant hand
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillemin François, MD, PUPH principal investigator
Institut de Cancérologie de Lorraine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mobile spectrofluorimeter in people with Healthy Volunteers, run by Institut de Cancérologie de Lorraine at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraindividual reproducibility of measuring the natural and basal skin fluorescence (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2018.