Cryo-Touch III Refinement Study Investigational Plan

Study Overview
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Brief Summary
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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.

Conditions
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Facial Wrinkles, Skin Aging

Intervention / Treatment
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* Device: Cryo-Touch III


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br> | Device: Cryo-Touch III<br>* Percutaneous treatment with the device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wrinkle Severity and incidence of device-related serious adverse events | Effectiveness endpoint: Wrinkle severity in the target area in animation at 30 days post-treatment as rated by the investigator using the 5-point grading scale. Safety endpoint: Incidence of device-related serious adverse events (DSAE). | Up to 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wrinkle Severity | • Investigators' rating of wrinkle severity in the target area in animation immediately post-treatment, at 1 and 7 days post-treatment and at 30-day intervals for 120 days after treatment | Up to 4 months | 
| Independent Assessment | • Independent reviewers' ratings of forehead wrinkle severity at rest and in animation at 30-days post-treatment | Up to 4 months | 
| Global assessment | • Subjects' global assessment of change in appearance of target area immediately post-treatment, at 1 and 7 days post-treatment and at 30-day intervals for 120 days after treatment | Up to 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wrinkle rhytid aging