Cryo-Touch III Refinement Study Investigational Plan
Completed · Phase 2/Phase 3
Conditions studied: Facial Wrinkles, Skin Aging
In brief
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.
Key facts
- Study ID
- NCT01379365
- Run by
- Pacira Pharmaceuticals, Inc
- People needed
- 88
- Starts
- 2011-06-01
- Expected to finish
- 2014-12-01
- Last updated by the study team
- 2015-03-24
Who can join
Age: 30 and older, up to 70. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
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
- 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
Where it is running
- The Aesthetics Research Center — Redwood City, California, United States
Full record on ClinicalTrials.gov
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