NCT05630690

Evaluation of Safety and Efficacy of IPL Presets for Cutaneous Lesions

Evaluation of Safety and Efficacy of SMART Camera Treatment Presets for Cutaneous Lesions Using IPL in Skin Types I-V

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Lumenis Be Ltd. · Industry
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Accepted

Summary

Single-center, Prospective, Open-Label with Before-After Study Design. Each subject will receive up to three (3) consecutive treatments at 1-month interval. Treatment presets will be determined by the SMART Camera system and approved by the physician. Follow-up will take place at 1 month following the last treatment. Skin and lesion attributes will be examined by the SMART system and the physician on each visit and at follow-up.

Detailed description

Up to 20 healthy subjects, aged 21-80 years old with visible textural lesions including but not limited to Lentigines, Rosacea, and Age spots / Telangiectasia on the face or décolletage that wish to improve their skin appearance. Each patient should have at least 3 treatment areas (e.g. left cheek, right cheek, forehead, nose, chin, upper/lower décolletage) that contain at least one type of lesion. Following the SMART Camera analysis, the system will suggest treatment presets. The physician will decide whether to use the treatment presets recommended by the AI system or modify them, based on the safety and efficacy of the suggested treatment presets.

Conditions

• Vascular Lesion
• Pigmented Lesions

Interventions

Type	Name	Description
DEVICE	IPL with smart diagnostic handpiece	treatment with IPL following diagnostic with SMART system

Timeline

• Start date: 2023-10-04
• Primary completion: 2024-03-01
• Completion: 2024-04-01
• First posted: 2022-11-30
• Last updated: 2023-12-22

Locations

1 site across 1 country: Israel