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NCT01801826 · ClinicalTrials.gov registry record
A Prospective Study Evaluating the Treatment of Forehead and/or Glabellar Lines With the Cryo-Touch IV Device
A clinical trial, sponsored by Pacira Pharmaceuticals.
- Completed
- Registry status
- 61
- Enrollment target
NCT01801826: Completed study, sponsored by Pacira Pharmaceuticals.
NCT01801826 is a clinical trial that has completed, run by Pacira Pharmaceuticals. The registered enrollment target is 61 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01801826 has completed, sponsored by Pacira Pharmaceuticals.
- COMPLETED
- Registry status
- 61 participants
- Enrollment target
Study Summary
myoscience Inc. (Redwood City, CA) has developed a device for a novel, minimally invasive facial rejuvenation procedure designed to soften hyperdynamic facial lines. The myoscience Cryo-Touch IV device uses well-established principles of cryobiology to cause localized reduction in muscle activity resulting in a reversible reduction in facial animation and the appearance of facial lines. The device operates on well-established cryobiology principles; that localized exposure to controlled low temperature conditions can alter tissue function. The therapy treats targeted motor nerves with low temperatures via a cold probe in the form of an assembly of small diameter needles, creating a highly localized treatment zone around the probe. The thermal algorithm is designed to produce a reversible loss of nerve conduction resulting in a temporary decrease in muscle contractility. Prior studies of Cryo-Touch, Cryo-Touch II and Cryo-Touch III have provided strong evidence of effectiveness and safety for applications in this indication. The goal of the study described herein is to show the safety and effectiveness of this approach using the Cryo-Touch IV device.
Primary Outcome
Wrinkle severity in the target area in animation at 30 days post-treatment as rated by the investigator using the 5-point grading scale.
Interventions
- DEVICE Treatment with CryoTouch IV
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2013-01 |
| Est. Completion | 2014-12 |
What the finished NCT01801826 record still lists
NCT01801826 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 61 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Treatment with CryoTouch IV is the first listed.
NCT01801826 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01801826 about?
NCT01801826 is a clinical study titled "A Prospective Study Evaluating the Treatment of Forehead and/or Glabellar Lines With the Cryo-Touch IV Device". myoscience Inc. (Redwood City, CA) has developed a device for a novel, minimally invasive facial rejuvenation procedure designed to soften hyperdynamic facial lines. The myoscience Cryo-Touch IV device uses well-established principles of cryobiology to cause localized reduction in muscle activity re...
What is the current status of trial NCT01801826?
This trial is currently completed. The enrollment target is 61 participants. The study started on 2013-01. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01801826?
The interventions under investigation include: Treatment with CryoTouch IV (DEVICE).
Who is sponsoring clinical trial NCT01801826?
This trial is sponsored by Pacira Pharmaceuticals, which has 88 total clinical trials registered on ClinicalTrials.gov.
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