Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01447342 | A Study to Evaluate the Safety and Effectiveness of the Cryo-Touch II Device for the Treatment of Forehead and/or Glabellar Lines | PHASE2 | COMPLETED | 54 | — | — | Sep 1, 2011 | Aug 1, 2012 | Mar 24, 2015 | 3 | United States |
| NCT01167140 | Cryo-Touch II for the Treatment of Wrinkles | PHASE2 | COMPLETED | 42 | — | — | Jul 1, 2010 | Apr 1, 2011 | Jan 24, 2024 | 1 | United States |
Effectiveness endpoint: wrinkle severity in the forehead in animation at 30 days post-treatment (Visit 5) as rated by the investigator/designee using the 5-point Wrinkle Scale (5WS).
Safety endpoint: Tolerability of treatment (LSRs), local and systemic adverse events will be assessed at all visits. Incidence of serious adverse events (SAEs) and unanticipated adverse device effects (UADEs) will be recorded. A serious adverse event is one that meets the ISO definition of SAE .
* 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)
| Arm | Type | Description |
|---|---|---|
| Cryo-Touch II | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Cryo-Touch II | DEVICE | Percutaneous treatment with the device |
Inclusion Criteria: 1. Subject is a male or female, 30 to 70 years old. 2. Subject is willing and able to give written informed consent. 3. Subject has a forehead wrinkle rating by the investigator/designee of at least "2" in animation on the 5-point Wrinkle Scale (5WS) which upon physical manipula...