Cryo-Touch II for the Treatment of Wrinkles

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MyoScience, Inc
ClinicalTrials.gov Identifier:
NCT01167140
First received: July 20, 2010
Last updated: August 29, 2012
Last verified: August 2012
  Purpose

This is a prospective, non-randomized study to evaluate the performance of the MyoScience Cryo-Touch II device for the treatment of wrinkles.


Condition Intervention Phase
Facial Wrinkles
Device: Cryo-Touch II
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by MyoScience, Inc:

Primary Outcome Measures:
  • Number of Participants With Effectiveness and Safety Success [ Time Frame: Up to 4 months ] [ Designated as safety issue: Yes ]
    • 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)


Secondary Outcome Measures:
  • Participants With One Point Improvement in Line Severity [ Time Frame: Baseline and up to 4 months ] [ Designated as safety issue: No ]
    • Investigators' rating of line severity improvement in the target area in animation at 7 days post-treatment, and at 30-day intervals for 120 days after treatment from baseline

  • Participants With an Improvement in Global Appearance [ Time Frame: Up to 4 months ] [ Designated as safety issue: No ]
    • Subjects' global assessment of change in appearance of target area at 7 days post-treatment, and at 30-day intervals for 120 days after treatment to baseline


Enrollment: 42
Study Start Date: July 2010
Study Completion Date: April 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cryo-Touch II Device: Cryo-Touch II
Percutaneous treatment with the device

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 30-70 years
  • Subject has a glabellar and/or forehead wrinkle rating by investigator of at least 1 at rest on the 5-point Wrinkle Scale (5WS)*
  • Subject has signed IRB-approved informed consent form

Exclusion Criteria:

  • Subject takes any medication or dietary supplement regularly that affects blood clotting (e.g., Coumadin, aspirin, clopidogrel) or increases the risk of bleeding/bruising
  • Subject has had prior surgery that alters the subcutaneous anatomy of the target treatment sites
  • The investigator is unable to substantially lessen facial lines by physical separation
  • Subject has undergone another facial cosmetic procedures at or above the level of the cheekbones within the past 6 months
  • Subject is participating in another facial cosmetic research study

Patient has any of following conditions:

  • History of facial nerve palsy
  • Marked facial asymmetry
  • Ptosis
  • Excessive dermatochalasis
  • Deep dermal scarring
  • Thick sebaceous skin
  • History of neuromuscular disorder
  • Chronic dry eye symptoms
  • Allergy or intolerance to lidocaine
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01167140

Locations
United States, California
The Aesthetics Research Center
Redwood City, California, United States, 94063
Sponsors and Collaborators
MyoScience, Inc
  More Information

No publications provided

Responsible Party: MyoScience, Inc
ClinicalTrials.gov Identifier: NCT01167140     History of Changes
Other Study ID Numbers: MS-4000
Study First Received: July 20, 2010
Results First Received: May 23, 2012
Last Updated: August 29, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 14, 2014