This is a prospective, non-randomized study to evaluate the performance of the MyoScience Cryo-Touch II device for the treatment of wrinkles.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Percutaneous treatment with the device
The Aesthetics Research Center
Redwood City, California, United States
Number of Participants With Effectiveness and Safety Success
* Effectiveness success: an improvement in line severity in the target area in animation at 30 days post-treatment as rated by the investigator using the 5-point wrinkle scale * Safety success: the absence of a device-related serious adverse event (DSAE)
Time frame: Up to 4 months
Participants With One Point Improvement in Line Severity
• Investigators' rating of line severity improvement in the target area in animation at 7 days post-treatment, and at 30-day intervals for 120 days after treatment from baseline
Time frame: Baseline and up to 4 months
Participants With an Improvement in Global Appearance
• Subjects' global assessment of change in appearance of target area at 7 days post-treatment, and at 30-day intervals for 120 days after treatment to baseline
Time frame: Up to 4 months
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