Medical Device Based on Polarized Light for Cutaneous Lesions Visualization (DERMAPOL)

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.

Study Overview

• Status: Terminated
• Conditions: Skin Lesion
• Intervention / Treatment: Device: Dermapol

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67091
    • Hopitaux universitaires de Strasbourg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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
  • 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

Exclusion Criteria:

• skin lesion size strictly over than 5 cm
• eyelid lesion
• aluminium, POM (polyoxymethylene) or organic glass allergy
• known pregnancy, breast-feeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dermapol; Use of the experimental medical device	Device: Dermapol; Use of the experimental medical device before lesion excision : skin lesion lighting (4 wavelengths) for less than 1 minute and image recording

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Before biopsy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physico-optical description of the lesions	Physico-optical description of the cutaneous lesions by the medical device	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	Before biopsy
Proportion of semiological characteristics properly identified	Proportion of semiological characteristics properly identified by the medical device for all lesions	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	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	Before biopsy

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Bernard CRIBIER, MD, Hopitaux universitaires de Strasbourg

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2019
• Primary Completion (Actual): January 14, 2024
• Study Completion (Actual): January 14, 2024

Study Registration Dates

• First Submitted: December 6, 2018
• First Submitted That Met QC Criteria: January 7, 2019
• First Posted (Actual): January 8, 2019

Study Record Updates

• Last Update Posted (Actual): August 3, 2025
• Last Update Submitted That Met QC Criteria: August 1, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 6798

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No