Skin LesionDERMAPOLNCT03796871
Medical Device Based on Polarized Light for Cutaneous Lesions Visualization
A study testing Dermapol in people with Skin Lesion, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Skin cancers represent a real public health issue. The diagnosis of pre-cancerous lesions thus is a priority. The diagnosis gold standard is based on the combination of clinical and histopathological examinations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Lesion
- What is being tested?
- Dermapol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jun 2019to 14 Jan 2024
- 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
- adult patient with a skin tumor (benign or cancerous) which has to be excised and analysed according to histopathological examination
- skin lesion belonging to one of these groups (diagnosed by clinical examination):
- cutaneous cyst
- seborrhoeic keratosis
- cutaneous carcinoma
- naevus
Show all 12Show fewer
- melanoma
- actinic keratosis and cutaneous horn
- other skin tumors
- skin lesion size equal to or less than 5 cm
- signed written consent form
- patient affiliated to a social insurance
Who cannot join
- skin lesion size strictly over than 5 cm
- eyelid lesion
- aluminium, POM (polyoxymethylene) or organic glass allergy
- known pregnancy, breast-feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interest of a New Medical Device for the Visualization of Cutaneous Lesions Based on Polarized Light
Skin cancers represent a real public health issue. The diagnosis of pre-cancerous lesions thus is a priority. The diagnosis gold standard is based on the combination of clinical and histopathological examinations. Nevertheless, the clinical examination is not sufficiently effective, meaning that a biopsy has to be done for each suspected lesion. In order to avoid unnecessary biopsy excisions, a new medical device (DERMAPOL) was designed to help dermatologists in diagnosing skin lesions.
This medical device combined with its software is a strong and ergonomic spectro-polarimetric imager instrument. It can realize images of the superficial cutaneous tissues and subcutaneous tissues close to the surface by exploiting polarized light properties.
This first clinical trial aims to demonstrate that this medical device is able to segment effectively healthy and tumor tissues and that it can correlate main semiological elements (identified thanks to the clinical and histopathological examinations) to the physico-optical characteristics obtained on the images of the medical device.
- Conditions
- Skin Lesion
- Being tested
- Dermapol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DermapolDevice
Use of the experimental medical device before lesion excision : skin lesion lighting (4 wavelengths) for less than 1 minute and image recording
| Study group | Role | What they receive |
|---|---|---|
| Dermapol | Experimental | Use of the experimental medical device Receives: Device: Dermapol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of lesions with semiological characteristics
Proportion of lesions for which at least one semiological characteristic (detected by the combination of visual and histopathological examinations) was identified by the medical device thanks to physico-optical properties
Measured: Before biopsy
Secondary outcomes (5)
Physico-optical description of the lesions
Physico-optical description of the cutaneous lesions by the medical device
Measured: Before biopsy
Number of different semiological characteristics
Number of different semiological characteristics visualized by the medical device and by the combination of clinical and histopathological examinations for each image processing
Measured: Before biopsy
Proportion of semiological characteristics properly identified
Proportion of semiological characteristics properly identified by the medical device for all lesions
Measured: Before biopsy
Specificity, sensitivity and predictive values
Specificity, sensitivity, true positive rate, true negative rate, false positive rate, false negative rate of the medical device, for each semiological characteristic identified by the combination of the clinical and histopathological examinations
Measured: Before biopsy
Cases proportion for which the same semiological characteristics list was found between the medical device and the combination of clinical and histopathological diagnosis
Proportion of cases with same semiological characteristics list
Measured: Before biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start19 Jun 2019
- Primary completion14 Jan 2024
- Study completion14 Jan 2024
Why it stopped: not enough patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin LesionStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernard CRIBIER, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03796871
- Sponsor's protocol ID
- 6798
- Acronym
- DERMAPOL
- Status last verified
- Aug 2025
- First submitted
- 6 Dec 2018
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of a New Medical Device for the Visualization of Cutaneous Lesions Based on Polarized Light
- ClinicalTrials.gov ID
- NCT03796871
- Acronym / sponsor ID
- DERMAPOL / 6798
- Conditions
- Skin Lesion
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: not enough patients
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 19 Jun 2019 (actual)
- Primary completion
- 14 Jan 2024 (actual)
- Study completion
- 14 Jan 2024 (actual)
- First posted
- 8 Jan 2019 (actual)
- 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.
Skin cancers represent a real public health issue. The diagnosis of pre-cancerous lesions thus is a priority. The diagnosis gold standard is based on the combination of clinical and histopathological examinations. Nevertheless, the clinical examination is not sufficiently effective, meaning that a biopsy has to be done for each suspected lesion. In order to avoid unnecessary biopsy excisions, a new medical device (DERMAPOL) was designed to help dermatologists in diagnosing skin lesions.
This medical device combined with its software is a strong and ergonomic spectro-polarimetric imager instrument. It can realize images of the superficial cutaneous tissues and subcutaneous tissues close to the surface by exploiting polarized light properties.
This first clinical trial aims to demonstrate that this medical device is able to segment effectively healthy and tumor tissues and that it can correlate main semiological elements (identified thanks to the clinical and histopathological examinations) to the physico-optical characteristics obtained on the images of the medical device.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dermapol | Experimental | Device: DermapolUse of the experimental medical device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- adult patient with a skin tumor (benign or cancerous) which has to be excised and analysed according to histopathological examination
- skin lesion belonging to one of these groups (diagnosed by clinical examination):
- skin lesion size equal to or less than 5 cm
- signed written consent form
- patient affiliated to a social insurance
Key exclusion criteria (4 listed)
- skin lesion size strictly over than 5 cm
- eyelid lesion
- aluminium, POM (polyoxymethylene) or organic glass allergy
- known pregnancy, breast-feeding
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 |
|---|---|---|
| DermapolUse of the experimental medical device before lesion excision : skin lesion lighting (4 wavelengths) for less than 1 minute and image recording | Device | Dermapol |
Primary outcome
Proportion of lesions with semiological characteristics
Time frame: Before biopsy
Proportion of lesions for which at least one semiological characteristic (detected by the combination of visual and histopathological examinations) was identified by the medical device thanks to physico-optical properties
5 secondary outcomes
Physico-optical description of the lesions
Time frame: Before biopsy
Number of different semiological characteristics
Time frame: Before biopsy
Proportion of semiological characteristics properly identified
Time frame: Before biopsy
Specificity, sensitivity and predictive values
Time frame: Before biopsy
Cases proportion for which the same semiological characteristics list was found between the medical device and the combination of clinical and histopathological diagnosis
Time frame: Before biopsy
Results and safety
The study was stopped early (reason given: not enough patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Bernard CRIBIER, MD principal investigator
Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dermapol in people with Skin Lesion, run by University Hospital, Strasbourg, France 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 12 inclusion and 4 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: stopped early, as of the sponsor's last update on 3 Aug 2025. 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 was stopped early (reason given: not enough patients). Results are not available in the source record.
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?
Proportion of lesions with semiological characteristics (time frame: Before biopsy). 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 3 Aug 2025.