Image Data Collection Using a Multi-spectral Camera for Computer Vision Algorithms Research and Development

Pigmented Lesions Clinical Trial

Official title:

Image Data Collection Using a Multi-spectral Camera for Computer Vision Algorithms Research and Development

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05674149
• Other study ID #: LUM-ABU-SMRT-22-04
• Status: Recruiting
• Phase: N/A
• Start date: June 21, 2023
• Est. completion date: March 2024

Study information

• Verified date: December 2023
• Source: Lumenis Be Ltd.
• Contact: Rula Masoud, PhD
• Phone: 0503018155
• Email: rula.masoud[@]lumenis.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an observational, single-center, open-label photography evaluation. Any patient that arrives for consultation or treatment at the clinic, presenting the required lesions detailed in the protocol can be included.

Description:

This is an observational, single-center, open-label photography evaluation. Any patient that arrives for consultation or treatment at the clinic, presenting the required lesions detailed in the protocol can be included.

The specified lesions can be located on any area of the face or body. For consenting subjects at least 5 close-up images of at least one lesion and one reference image (e.g., subject's skin without any lesion) will be obtained using the Multi-spectral SMART camera. An additional reference image of the lesion area will be taken with a regular camera. Optional images may be taken using a dermatoscop

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Subjects must meet all the following inclusion criteria to be entered into the study:

Any patient, male or female of at least 18 years old, who is willing to sign an informed consent form and present at least one of the following conditions:

1. Photoaging (type I - III per Glogau classification)- mixed conditions

2. Epidermal pigmentation / Lentigines (age spots, sun spots)

3. Facial rosacea (Erythematotelangiectatic rosacea and papulopustular rosacea)

4. Facial telangiectasia

5. Poikiloderma

6. Seborrheic keratosis

7. Melasma (Chloasma)

Exclusion Criteria:

Any of the following will exclude the subject from the study:

The study is intended to gather image data so, any patient can be included in the study, and no exclusion criteria apply.

Related Conditions & MeSH terms

• Pigmented Lesions
• Vascular Lesion

Intervention

Device:
• camera
photographs using multi-spectral camera

Locations

Country	Name	City	State
Israel	Ha'Emek Medical Center	Afula

Sponsors (2)

Lead Sponsor	Collaborator
Lumenis Be Ltd.	Emek Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Images collection	Images of different skin condition will be collected using multispectral camera	through study completion, up to 4 months
Secondary	Images data collection	for each collected image using multispectral camera, skin an lesion attributes will be evaluated by the investigator. the following attribute will be collected: skin type, lesion type, lesion intensity	through study completion, up to 4 months