Wrinkle Clinical Trial
Official title:
Clinical Assessment of the Performance of a Fractional CO2 Laser System (Fraxel Repair Laser) Intended for Treatment of Perioral Rhytides/Wrinkles
Objective 1: To evaluate the effect and histologic (cellular) changes associated with varying
energy and density settings of the Fraxel Repair Laser to determine an optimal dose response.
Objective 2: To evaluate the clinical response associated with variable energy and density
settings of fraxel laser treatment in the upper lip. Overall assessment of clinical outcome
and safety will be based clinic visits and evaluation of pre- and post- procedural photos.
The subject's assessment of satisfaction will be characterized using a non-parametric
assessment scale at each follow-up period.
To evaluate the clinical response associated with variable energy and density settings of
fraxel laser treatment in the upper lip. Overall assessment of clinical outcome and safety
will be based clinic visits and evaluation of pre- and post- procedural photos. The subject's
assessment of satisfaction will be characterized using a non-parametric assessment scale at
each follow-up period.
This is a multi-site, non-randomized, non-controlled investigator initiated study designed to
follow a total of 30 qualified and consenting subjects treated with one Fraxel Repair
treatment in the course of clinical practice.
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