IPL with smart diagnostic handpiece
Devicetreatment with IPL following diagnostic with SMART system
NCT Number: NCT05755139
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
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Notify Me21 year–80 year
All sexes
Interventional
Not applicable
Westlake Dermatology, Austin, Texas, United States
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
treatment with IPL following diagnostic with SMART system
Time frame: 3 month
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: 4 months
Lesions clearance will be evaluated by the investigator at a 1-month follow-up compared to baseline using a 5-point clearance scale, when 0 is no clearance, and 4 is 76-100% clearance.
Evaluation will be completed through study completion, an average of 4 months.
Lumenis Be Ltd.
Industry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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