This is a prospective, non-randomized study to evaluate the performance of the MyoScience Cryo-Touch III device for the treatment of glabellar and/or forehead wrinkles.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
88
Percutaneous treatment with the device
The Aesthetics Research Center
Redwood City, California, United States
Wrinkle Severity and incidence of device-related serious adverse events
* Effectiveness endpoint: Wrinkle severity in the target area in animation at 30 days post-treatment as rated by the investigator using the 5-point grading scale. * Safety endpoint: Incidence of device-related serious adverse events (DSAE).
Time frame: Up to 4 months
Wrinkle Severity
• Investigators' rating of wrinkle severity in the target area in animation immediately post-treatment, at 1 and 7 days post-treatment and at 30-day intervals for 120 days after treatment
Time frame: Up to 4 months
Independent Assessment
• Independent reviewers' ratings of forehead wrinkle severity at rest and in animation at 30-days post-treatment
Time frame: Up to 4 months
Global assessment
• Subjects' global assessment of change in appearance of target area immediately post-treatment, at 1 and 7 days post-treatment and at 30-day intervals for 120 days after treatment
Time frame: Up to 4 months
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