Photoaging Clinical Trial
Official title:
Multi-center, Multi-cohort, Prospective, Open-label Study of VELOS for Treatment of Vascular Skin Disorders
This is a multi-center, multi-cohort, prospective, open-label study of VELOS for treatment of vascular skin disorders. The plan is to enroll up to 60 subjects from up to 3 centers in the US and worldwide. The purpose is to collect data from the use of VELOS.
The primary objective of this trial is to collect data from the use of VELOS in clinical
practice under a wide range of treatment parameters variability including RF energy, laser
fluence, and laser pulse duration for treating each of the vascular disorders. This will be
conducted by documenting the physician selected treatment parameters, as well as the
subjects' clinical clearing response, perception of improvement and sensations, through the
study treatments and post-treatment(s) follow-up visits.
Optional exploratory objectives: Collection of safety and efficacy data of the Velos with DCD
cooling and Velos with contact cooling. The investigator may opt to include in this study
noninvasive measurements of erythema, melanin and texture (which may be performed by eg.
Chromameter, Mexameter or 3D imaging), and measurements of linear vessel diameters and lesion
size.
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