Cryo-Touch III Refinement Study Investigational Plan
| Status: | Completed | 
|---|---|
| Conditions: | Cosmetic | 
| Therapuetic Areas: | Dermatology / Plastic Surgery | 
| Healthy: | No | 
| Age Range: | 30 - 70 | 
| Updated: | 11/8/2014 | 
| Start Date: | June 2011 | 
| End Date: | January 2013 | 
| Contact: | John Allison, PhD | 
| Email: | jallison@myoscience.com | 
| Phone: | 650-474-2600 | 
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.
			Cryo-Touch III device for the treatment of glabellar and/or forehead wrinkles.
Inclusion Criteria:
- 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
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
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
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