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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
20
treatment with IPL following diagnostic with SMART system
Lumenis Be Ltd.
Yokneam Illit, Israel
RECRUITINGTo study the safety of the SMART IPL system platform for cutaneous lesions treatment in subjects with skin types I-V
Treatment with the SMART IPL system will be considered safe when a full treatment is completed using the recommended presets by the AI system (presets are not overruled due to safety by the physician) with no serious AEs. The overall percentage of safe treatments using the AI-recommended presets from all treatments will be calculated through study completion, an average of 3 months.
Time frame: End of treatments
To study the efficacy of the SMART IPL system for cutaneous lesions treatment in subjects with skin types I-V
Lesions clearance evaluated by the investigator at a 1-month follow-up compared to baseline using a 5-point clearance scale.
Time frame: 1-month follow up
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