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Cryo-Touch III Refinement Study Investigational Plan

This study is currently recruiting participants.
Verified August 2012 by MyoScience, Inc
Sponsor:
Information provided by (Responsible Party):
MyoScience, Inc
ClinicalTrials.gov Identifier:
NCT01379365
First received: June 20, 2011
Last updated: August 27, 2012
Last verified: August 2012
History of Changes
  Purpose

This is a prospective, non-randomized study to evaluate the performance of the MyoScience Cryo-Touch III device for the treatment of glabellar and/or forehead wrinkles.


Condition Intervention Phase
Facial Wrinkles
Skin Aging
 Device: Cryo-Touch III
 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

Resource links provided by NLM:

MedlinePlus related topics: Skin Aging
U.S. FDA Resources

Further study details as provided by MyoScience, Inc:

Primary Outcome Measures:
  • Wrinkle Severity and incidence of device-related serious adverse events [ Time Frame: Up to 4 months ] [ Designated as safety issue: Yes ]
    • Effectiveness endpoint: Wrinkle severity in the target area in animation at 30 days post-treatment as rated by the investigator using the 5-point grading scale.
    • Safety endpoint: Incidence of device-related serious adverse events (DSAE).


Secondary Outcome Measures:
  • Wrinkle Severity [ Time Frame: Up to 4 months ] [ Designated as safety issue: No ]
    • Investigators' rating of wrinkle severity in the target area in animation immediately post-treatment, at 1 and 7 days post-treatment and at 30-day intervals for 120 days after treatment

  • Independent Assessment [ Time Frame: Up to 4 months ] [ Designated as safety issue: No ]
    • Independent reviewers' ratings of forehead wrinkle severity at rest and in animation at 30-days post-treatment

  • Global assessment [ Time Frame: Up to 4 months ] [ Designated as safety issue: No ]
    • Subjects' global assessment of change in appearance of target area immediately post-treatment, at 1 and 7 days post-treatment and at 30-day intervals for 120 days after treatment


Estimated Enrollment: 100
Study Start Date: June 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Device: Cryo-Touch III
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 2 in animation on the 5-point Wrinkle Scale (5WS)*
  • Subject has signed institutional review board (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
  • Other local skin condition (eg, skin infection) at target treatment site
  • Any physical or psychiatric condition that in the investigator's opinion would prevent adequate study participation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01379365

Contacts
Contact: John Allison, PhD 650-474-2600 ext 25 jallison@myoscience.com

Locations
United States, California
The Aesthetics Research Center Recruiting
Redwood City, California, United States, 94063
Contact: Stephanie Serna     800-442-0989        
Sponsors and Collaborators
MyoScience, Inc
  More Information

No publications provided

Responsible Party: MyoScience, Inc
ClinicalTrials.gov Identifier: NCT01379365     History of Changes
Other Study ID Numbers: MS-4500, MS-4500
Study First Received: June 20, 2011
Last Updated: August 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by MyoScience, Inc:
wrinkle rhytid aging

ClinicalTrials.gov processed this record on May 23, 2013