Cryo-Touch II for the Treatment of Wrinkles
1 other identifier
interventional
42
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2010
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 20, 2010
CompletedFirst Posted
Study publicly available on registry
July 22, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedResults Posted
Study results publicly available
October 1, 2012
CompletedJanuary 24, 2024
January 1, 2024
6 months
July 20, 2010
May 23, 2012
January 22, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Effectiveness and Safety Success
* 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)
Up to 4 months
Secondary Outcomes (2)
Participants With One Point Improvement in Line Severity
Baseline and up to 4 months
Participants With an Improvement in Global Appearance
Up to 4 months
Study Arms (1)
Cryo-Touch II
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Aesthetics Research Center
Redwood City, California, 94063, United States
Results Point of Contact
- Title
- Francis Rogers Palmer III, MD
- Organization
- Myoscience
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2010
First Posted
July 22, 2010
Study Start
July 1, 2010
Primary Completion
January 1, 2011
Study Completion
April 1, 2011
Last Updated
January 24, 2024
Results First Posted
October 1, 2012
Record last verified: 2024-01