Cryo-Touch II for the Treatment of Wrinkles

Pacira

Status and phase: Completed; Phase 3; Phase 2

Conditions: Facial Wrinkles

Treatments: Device: Cryo-Touch II

Study type: Interventional

Funder types: Industry

Identifiers

NCT01167140

MS-4000

Details and patient eligibility

About

This is a prospective, non-randomized study to evaluate the performance of the MyoScience Cryo-Touch II device for the treatment of wrinkles.

Enrollment: 42 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

Cryo-Touch II

Experimental group

Treatment:

Device: Cryo-Touch II