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NCT01808742 · ClinicalTrials.gov registry record
Study Evaluating the Treatment of Forehead and/or Glabellar Lines With the CRYO-TOUCH III Device
A clinical trial of Glabellar Frown Lines and Frown Lines, sponsored by Pacira Pharmaceuticals.
- Completed
- Registry status
- 17
- Enrollment target
- 1
- Study location
NCT01808742: Completed study of Glabellar Frown Lines and Frown Lines, sponsored by Pacira Pharmaceuticals.
NCT01808742 is a study of Glabellar Frown Lines and Frown Lines that has completed, run by Pacira Pharmaceuticals. The registered enrollment target is 17 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01808742, a study of Glabellar Frown Lines and Frown Lines, has completed, sponsored by Pacira Pharmaceuticals.
- COMPLETED
- Registry status
- 17 participants
- Enrollment target
- 1
- Study location
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 III 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 investigate optimized algorithms and ongoing safety and effectiveness.
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.
Conditions Studied
Interventions
- DEVICE Treatment with CryoTouch III Device
Study Locations (1)
California
- 77 Plastic Surgery - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2012-11 |
| Est. Completion | 2014-08 |
What the finished NCT01808742 record still lists
NCT01808742 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 17 participants, a relatively small participant target.
The record links to 2 conditions, with Glabellar Frown Lines appearing as the primary indexed condition, and to 1 intervention - of which Treatment with CryoTouch III Device is the first listed.
NCT01808742 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01808742 about?
NCT01808742 is a clinical study titled "Study Evaluating the Treatment of Forehead and/or Glabellar Lines With the CRYO-TOUCH III 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 III device uses well-established principles of cryobiology to cause localized reduction in muscle activity r...
What is the current status of trial NCT01808742?
This trial is currently completed. The enrollment target is 17 participants. The study started on 2012-11. Estimated completion is 2014-08.
What conditions does trial NCT01808742 study?
This clinical trial studies the following conditions: Glabellar Frown Lines, Frown Lines.
What interventions are being tested in trial NCT01808742?
The interventions under investigation include: Treatment with CryoTouch III Device (DEVICE).
Who is sponsoring clinical trial NCT01808742?
This trial is sponsored by Pacira Pharmaceuticals, which has 88 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01808742 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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