Status:
COMPLETED
Cryo-Touch II for the Treatment of Wrinkles
Lead Sponsor:
Pacira Pharmaceuticals, Inc
Conditions:
Facial Wrinkles
Eligibility:
All Genders
30-70 years
Phase:
PHASE2
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01167140
Start Date
July 1 2010
End Date
April 1 2011
Last Update
January 24 2024
Active Locations (1)
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1
The Aesthetics Research Center
Redwood City, California, United States, 94063