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Cryo-Touch II · 2 trials · 2 indications
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...
Cryo-Touch II is an investigational device being studied for the treatment of facial wrinkles, including forehead and glabellar lines. It is intended to address signs of skin aging. The device is currently in clinical development and has not been approved by the FDA.
Cryo-Touch II is developed by Pacira BioSciences, Inc., a company traded on the NASDAQ under the ticker PCRX. The company is conducting clinical trials to evaluate the safety and effectiveness of this device for facial wrinkles.
Cryo-Touch II is in Phase 2 clinical development. Two Phase 2 trials have been completed, with a total of 96 participants enrolled. The device remains investigational and is not yet approved for commercial use.
Cryo-Touch II has been studied in two completed Phase 2 trials. NCT01167140 enrolled 42 participants to evaluate the device for treating wrinkles, and NCT01447342 enrolled 54 participants to assess its safety and effectiveness for forehead and glabellar lines. Both trials were conducted in the United States.
The mechanism of action for Cryo-Touch II has not been disclosed. It is a device-based treatment being evaluated for facial wrinkles, but specific details about how it achieves its effects are not available.