NCT05755139

Safety and Efficacy Evaluation of SMART Camera Treatment Presets for Cutaneous Lesions Using IPL

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Lumenis Be Ltd. · Industry
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Accepted

Summary

Multi-center, Prospective, Open-Label with Before-After Study Design. Each subject will receive a single treatment. 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 treatment. Skin and lesion attributes will be examined by the SMART system and the physician

Detailed description

At least 40 healthy subjects in 2 sites, 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 contains at least one type of lesion

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: 2022-12-04
• Primary completion: 2023-06-23
• Completion: 2023-08-15
• First posted: 2023-03-06
• Last updated: 2023-12-22

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study