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

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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.


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
We found this trial at
1
site
Redwood City, California 94063
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from
Redwood City, CA
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