Image Data Collection of Tanned Skin During Phototherapy Treatment Using a Multi-spectral Camera

NCT05692544 | Unknown

• 1 other identifier: LUM-ABU-SMRT-22-03
• Study Type: observational
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective, observational, single-center, image collection study. Any patient who arrived at the phototherapy clinic for the first time, regardless of this study, and is prescribed a total of 30 treatments can be included, regardless of skin or medical condition. After consenting subjects at least 5 close-up images will be taken from the specified anatomical areas, at different angles, using the SMART camera. Additional reference images of skin that is not exposed to the phototherapy treatment will be taken with the SMART Camera. Global image of the skin using a regular high-resolution camera is optional. The images will be collected on baseline visit, at least every 3 phototherapy treatments (approximately once a week), and at the last phototherapy treatment visit. i.e., in total of at least 11 phototherapy treatment visits. Follow-up images will be taken at 1-week and 2 weeks following the last phototherapy treatment. Images shall be taken from any anatomical area that does not consist of any marked lesions or skin conditions. All images will be non-identifying.

Conditions

Pigment; Lesion; Lesion; Vascular

Outcome Measures

Primary Outcomes (1)

• Image data

  Images will be collected through the study

  4-months

Interventions

Phototherapy treatment PROCEDURE

only patients was proscribe to phototherapy treatment can participate in the study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Up to 10 subjects should be included in this study.

You may qualify if:

• Any patient, male or female 18 years or older.
• Patient is scheduled for 30 treatments or more of phototherapy
• Subject is capable and willing to sign an informed consent
• Subject is willing to comply with study schedule
• Subject has areas of skin that do not consist any marked lesions, hairs or skin conditions and can be captured in the study

You may not qualify if:

• Subjects incapable of providing an informed consent

Sponsors & Collaborators

• Lumenis Be Ltd.: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: January 20, 2023
• Study Start: November 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: October 6, 2023

Record last verified: 2023-04