Cryo-Touch II for the Treatment of Wrinkles

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01167140
Recruitment Status : Completed
First Posted : July 22, 2010
Results First Posted : October 1, 2012
Last Update Posted : October 1, 2012
Information provided by (Responsible Party):
MyoScience, Inc

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

Condition or disease Intervention/treatment Phase
Facial Wrinkles Device: Cryo-Touch II Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : July 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : April 2011

Arm Intervention/treatment
Experimental: Cryo-Touch II Device: Cryo-Touch II
Percutaneous treatment with the device

Primary Outcome Measures :
  1. Number of Participants With Effectiveness and Safety Success [ Time Frame: Up to 4 months ]
    • 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 :
  1. Participants With One Point Improvement in Line Severity [ Time Frame: Baseline and up to 4 months ]
    • 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

  2. Participants With an Improvement in Global Appearance [ Time Frame: Up to 4 months ]
    • 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

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01167140

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

Responsible Party: MyoScience, Inc Identifier: NCT01167140     History of Changes
Other Study ID Numbers: MS-4000
First Posted: July 22, 2010    Key Record Dates
Results First Posted: October 1, 2012
Last Update Posted: October 1, 2012
Last Verified: August 2012