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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014