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Cryo-Touch III Refinement Study Investigational Plan

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ClinicalTrials.gov Identifier: NCT01379365
Recruitment Status : Completed
First Posted : June 23, 2011
Last Update Posted : March 24, 2015
Sponsor:
Information provided by (Responsible Party):
MyoScience, Inc

June 20, 2011
June 23, 2011
March 24, 2015
June 2011
December 2014   (Final data collection date for primary outcome measure)
Wrinkle Severity and incidence of device-related serious adverse events [ Time Frame: Up to 4 months ]
  • 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).
Not Provided
Complete list of historical versions of study NCT01379365 on ClinicalTrials.gov Archive Site
  • Wrinkle Severity [ Time Frame: Up to 4 months ]
    • 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 ]
    • 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 ]
    • 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
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Cryo-Touch III Refinement Study Investigational Plan
Not Provided
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.
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Interventional
Phase 2
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Facial Wrinkles
  • Skin Aging
Device: Cryo-Touch III
Percutaneous treatment with the device
Experimental: Treatment
Intervention: Device: Cryo-Touch III
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
88
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December 2014
December 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
30 Years to 70 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01379365
MS-4500
MS-4500
No
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MyoScience, Inc
MyoScience, Inc
Not Provided
Not Provided
MyoScience, Inc
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP