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A Prospective Study Evaluating the Treatment of Forehead and/or Glabellar Lines With the Cryo-Touch IV Device

NCT01801826 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 61

Last updated 2015-03-24

No results posted yet for this 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.

Conditions

  • Frown Lines
  • Glabellar Frown Lines

Interventions

DEVICE

Treatment with CryoTouch IV

Bilateral forehead treatment with the Cryo-Touch IV device on the temporal branch of the facial nerve. Subject will be treated once and may have a retreatment up to 7 days after the first treatment

Sponsors & Collaborators

  • Pacira Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • Larry K Fan, MD · 77 Plastic Surgery

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2014-05-31
Completion
2014-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01801826 on ClinicalTrials.gov