Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
42 participants
INTERVENTIONAL
2010-07-31
2011-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cryo-Touch II
Cryo-Touch II
Percutaneous treatment with the device
Interventions
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Cryo-Touch II
Percutaneous treatment with the device
Eligibility Criteria
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Inclusion Criteria
* 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 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
30 Years
70 Years
ALL
Yes
Sponsors
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Pacira Pharmaceuticals, Inc
INDUSTRY
Responsible Party
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Locations
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The Aesthetics Research Center
Redwood City, California, United States
Countries
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Other Identifiers
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MS-4000
Identifier Type: -
Identifier Source: org_study_id
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