Facial Wrinkles, Skin Aging
Conditions
Keywords
wrinkle rhytid aging
Brief summary
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.
Interventions
DEVICECryo-Touch III
Percutaneous treatment with the device
Sponsors
Pacira Pharmaceuticals, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 30-70 years * Subject has a glabellar and/or forehead wrinkle rating by investigator of at least 2 in animation on the 5-point Wrinkle Scale (5WS)\* * Subject has signed institutional review board (IRB)-approved informed consent form
Exclusion criteria
* Subject takes any medication or dietary supplement regularly that affects blood clotting (e.g., Coumadin, aspirin, clopidogrel) or increases the risk of bleeding/bruising * Subject has had prior surgery that alters the subcutaneous anatomy of the target treatment sites * The investigator is unable to substantially lessen facial lines by physical separation * Subject has undergone another facial cosmetic procedures at or above the level of the cheekbones within the past 6 months * Subject is participating in another facial cosmetic research study Patient has any of following conditions: * History of facial nerve palsy * Marked facial asymmetry * Ptosis * Excessive dermatochalasis * Deep dermal scarring * Thick sebaceous skin * History of neuromuscular disorder * Chronic dry eye symptoms * Allergy or intolerance to lidocaine * Other local skin condition (eg, skin infection) at target treatment site * Any physical or psychiatric condition that in the investigator's opinion would prevent adequate study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wrinkle Severity and incidence of device-related serious adverse events | Up to 4 months | * 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wrinkle Severity | Up to 4 months | • 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 |
| Independent Assessment | Up to 4 months | • Independent reviewers' ratings of forehead wrinkle severity at rest and in animation at 30-days post-treatment |
| Global assessment | Up to 4 months | • 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 |
Countries
United States
Outcome results
None listed