Study of the MyoScience Tissue Remodeling Device for Facial Rejuvenation

Study Overview
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Brief Summary
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A prospective, non-randomized study to evaluate the performance of the MyoScience Tissue Remodeling Device for the treatment of glabellar lines (frown lines), lateral orbital lines (crow's feet), and frontalis lines (horizontal forehead lines).

Official Title
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Study of the MyoScience Tissue Remodeling Device for Facial Rejuvenation

Conditions
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Facial Rhytides

Intervention / Treatment
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* Device: MyoScience Tissue Remodeling Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject must be a female 30 to 70 years of age. The subject must have a clinical examination prior to treatment including assessment of hyperdynamic line severity. The subject must have a wrinkle rating of at least 1 at rest in one or more of the following treatment areas (glabellar, lateral orbital, or frontalis). The subject must have signed an informed consent form. The subject should not have undergone any other facial cosmetic procedures at or above the level of the cheekbones within the past 6 months. The subject should not be participating in any other facial cosmetic research study. Exclusion Criteria: The subject is on a regular regimen of prescribed or over-the-counter anticoagulants. The subject has an infection or skin problem at the injection site. The subject has a history of facial nerve palsy. The subject has marked facial asymmetry. The subject has ptosis. The subject has excessive dermatochalasis. The subject has deep dermal scarring. The subject has thick sebaceous skin. The investigator is unable to substantially lessen facial lines by physical separation. The subject has a history of neuromuscular disorder. The subject has undergone prior surgery that alters the subcutaneous anatomy of the areas being treated. Subjects with laxity of the canthal tendon and/or with lower lid retraction, and subjects who recruit their zygomaticus major muscle to animate their crow's feet. The subject has any physical or psychiatric condition that in the investigator's opinion would warrant exclusion from the study or prevent the subject from completing the study.

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

Sexes Eligible for Study
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Female

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: MyoScience Tissue Remodeling Device<br> | Device: MyoScience Tissue Remodeling Device<br>* Percutaneous treatment with the MyoScience device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigators' and subjects'rating of line severity in the target areas at rest and in animation at each follow-up interval. |  | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  | Up to 6 months |