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Cryo-Touch III Refinement Study Investigational Plan

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
MyoScience, Inc
ClinicalTrials.gov Identifier:
NCT01379365
First received: June 20, 2011
Last updated: October 30, 2014
Last verified: October 2014
  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:


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: December 2014
Estimated Primary Completion Date: December 2014 (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
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: NCT01379365

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: NCT01379365     History of Changes
Other Study ID Numbers: MS-4500, MS-4500
Study First Received: June 20, 2011
Last Updated: October 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by MyoScience, Inc:
wrinkle rhytid aging

ClinicalTrials.gov processed this record on November 25, 2014