Facial Wrinkles
Conditions
Brief summary
This is a prospective, non-randomized study to evaluate the performance of the MyoScience Cryo-Touch II device for the treatment of wrinkles.
Interventions
DEVICECryo-Touch II
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 1 at rest on the 5-point Wrinkle Scale (5WS)\* * Subject has signed 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Effectiveness and Safety Success | Up to 4 months | * 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants With One Point Improvement in Line Severity | Baseline and up to 4 months | • 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 |
| Participants With an Improvement in Global Appearance | Up to 4 months | • 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 | 42 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Group 1 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants |
| Age, Continuous | 52 years STANDARD_DEVIATION 9 |
| Region of Enrollment United States | 42 participants |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 13 / 41 |
| serious Total, serious adverse events | 0 / 41 |
Outcome results
Primary
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
Population: All subjects treated were analyzed to the safety endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment Group | Number of Participants With Effectiveness and Safety Success | Effectiveness Success (n=36) | 30 participants |
| Treatment Group | Number of Participants With Effectiveness and Safety Success | Safety Success (n=41) | 41 participants |
Secondary
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
Population: 5 subjects were excluded from effectiveness analysis because they received a lower dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment Group | Participants With an Improvement in Global Appearance | 7 days post-treatment | 34 participants |
| Treatment Group | Participants With an Improvement in Global Appearance | 30 days post-treatment | 32 participants |
| Treatment Group | Participants With an Improvement in Global Appearance | 60 days post-treatment | 25 participants |
| Treatment Group | Participants With an Improvement in Global Appearance | 90 days post-treatment | 12 participants |
| Treatment Group | Participants With an Improvement in Global Appearance | 120 days post-treatment | 2 participants |
Secondary
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
Population: Of the 41 subjects treated, 5 were treated at a lower dose and excluded from the effectiveness measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment Group | Participants With One Point Improvement in Line Severity | 7 days post-treatment | 32 participants |
| Treatment Group | Participants With One Point Improvement in Line Severity | 60 days post-treatment | 19 participants |
| Treatment Group | Participants With One Point Improvement in Line Severity | 90 days post-treatment | 9 participants |
| Treatment Group | Participants With One Point Improvement in Line Severity | 120 days post-treatment | 2 participants |