A Study to Evaluate the Safety and Effectiveness of the Cryo-Touch II Device for the Treatment of Forehead and/or Glabellar Lines

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by MyoScience, Inc.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
MyoScience, Inc
ClinicalTrials.gov Identifier:
NCT01447342
First received: September 29, 2011
Last updated: February 10, 2012
Last verified: February 2012
  Purpose

A prospective, non-randomized, multicenter study to evaluate the safety and effectiveness of the cryo-touch II device for the treatment of forehead and/or glabellar lines


Condition Intervention Phase
Facial Wrinkles
Skin Aging
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

Resource links provided by NLM:


Further study details as provided by MyoScience, Inc:

Primary Outcome Measures:
  • Effectiveness success [ Time Frame: Up to 4 months ] [ Designated as safety issue: No ]
    Effectiveness endpoint: wrinkle severity in the forehead in animation at 30 days post-treatment (Visit 5) as rated by the investigator/designee using the 5-point Wrinkle Scale (5WS).

  • Safety success [ Time Frame: Up to 4 months ] [ Designated as safety issue: Yes ]
    Safety endpoint: Tolerability of treatment (LSRs), local and systemic adverse events will be assessed at all visits. Incidence of serious adverse events (SAEs) and unanticipated adverse device effects (UADEs) will be recorded. A serious adverse event is one that meets the ISO definition of SAE .


Estimated Enrollment: 110
Study Start Date: September 2011
Estimated Study Completion Date: May 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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:

  1. Subject is a male or female, 30 to 70 years old.
  2. Subject is willing and able to give written informed consent.
  3. Subject has a forehead wrinkle rating by the investigator/designee of at least "2" in animation on the 5-point Wrinkle Scale (5WS) which upon physical manipulation/separation of the skin demonstrates a reduction in wrinkle severity. Subject may also have a glabellar score of "1" or higher in animation on a 4-point scale.
  4. Subject is willing and able to comply with study instructions and commit to all follow-up visits for the duration of the study.
  5. Subject is in good general health and free of any disease state or physical condition that might impair evaluation of forehead and/or glabellar wrinkle rating or which, in the investigator's opinion, exposes the subject to an unacceptable risk by study participation.

Exclusion Criteria:

  1. Subject is currently enrolled in an investigational drug or device study.
  2. Subject has used an investigational drug or investigational device treatment within 30 days prior to first administration of the device.
  3. Subject has a clotting disorder or has used an anticoagulant (e.g., Coumadin, clopidogrel, etc.) within seven (7) days prior to administration of the device.
  4. Subject has used aspirin, or non-steroidal anti-inflammatory drugs (NSAIDs, e.g., ibuprofen, and naproxen) within seven (7) days prior to administration of the device.
  5. Subject has had prior surgery that alters the subcutaneous anatomy of the target treatment sites.
  6. Subject has undergone another facial cosmetic procedure at or above the level of the cheekbones within the past six (6) months.
  7. Subject has any of the following conditions:

    1. History of facial nerve palsy,
    2. Marked facial asymmetry,
    3. Ptosis,
    4. History of neuromuscular disorder,
    5. Chronic dry eye symptoms,
    6. Allergy or intolerance to lidocaine,
    7. Other local skin condition (e.g., skin infection) at target treatment site,
    8. Any physical or psychiatric condition that in the investigator's opinion would prevent adequate study participation.
    9. Chronic medical condition that in the investigator's opinion would affect study participation (such as diabetes, hepatitis, HIV, etc.).
    10. Any chronic condition contraindicated for the use of nerve mapping device including heart disease, use of a cardiac pacemaker, and pregnancy.
  8. Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) in the opinion of the investigator.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01447342

Locations
United States, California
Macro, Llc
Beverly Hills, California, United States, 90212
The Aesthetics Research Center
Redwood City, California, United States, 94063
Roseville Facial Plastic Surgery
Roseville, California, United States, 95661
Sponsors and Collaborators
MyoScience, Inc
  More Information

No publications provided

Responsible Party: MyoScience, Inc
ClinicalTrials.gov Identifier: NCT01447342     History of Changes
Other Study ID Numbers: MS-4400
Study First Received: September 29, 2011
Last Updated: February 10, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 17, 2014