Medical Device Based on Polarized Light for Cutaneous Lesions Visualization

NCT03796871 | Terminated

• 1 other identifier: 6798
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Physico-optical description of the lesions

  Before biopsy

• Number of different semiological characteristics

  Before biopsy

• Proportion of semiological characteristics properly identified

  Before biopsy

• Specificity, sensitivity and predictive values

  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

  Before biopsy

Study Arms (1)

Dermapol

EXPERIMENTAL

Use of the experimental medical device

Device: Dermapol

Interventions

Dermapol DEVICE

Use of the experimental medical device before lesion excision : skin lesion lighting (4 wavelengths) for less than 1 minute and image recording

Dermapol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

Study Officials

• Bernard CRIBIER, MD

  Hôpitaux Universitaires de Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: January 8, 2019
• Study Start: June 19, 2019
• Primary Completion: January 14, 2024
• Study Completion: January 14, 2024
• Last Updated: August 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)