CompletedInterventionalNot ApplicableUpdated Mar 12, 2026
Cryo-Touch II for the Treatment of Wrinkles | NCT01167140 | Trialant
CompletedInterventionalPhase 2Phase 3Updated Jan 24, 2024
Cryo-Touch II for the Treatment of Wrinkles
ClinicalTrials.gov ID
NCT01167140
Lead Sponsor
Pacira Pharmaceuticals, IncINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 2Phase 3
Enrollment
42Actual
Last Update Posted
Jan 24, 2024Actual
Start Date
Jul 2010
Primary Completion Date
Jan 2011Actual
Completion Date
Apr 2011Actual
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.
Facial Wrinkles
Cryo-Touch II
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
Eligibility Criteria
Inclusion Criteria:
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
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