Efficacy Trial for the Reduction of Glabellar Lines

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the ability of the Serene RF System to effectively improve the appearance of dynamic glabellar lines and sustain the effect for a minimum of 3 months.

Official Title
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Multicenter Efficacy Trial of the Serene RF System for the Reduction of Glabellar Lines

Conditions
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Rhytids in the Glabellar Region

Intervention / Treatment
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* Device: Serene RF System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Glabellar lines rating of at least two per the Merz Scale Written informed consent Understands and accepts the following obligations during the follow-up period (minimum of three months and up to one year) available for the 3 day phone call and present for each follow-up visit; receive NO other facial procedures in the upper face for a minimum of three months and up to one year after the RF procedure; make NO changes to the eyebrows for a minimum of three months after the RF procedure. Exclusion Criteria: Injection of botulinum toxin to the upper face within the previous four months Use of fillers in the upper face within the previous twelve months Use of prescription treatments (e.g., Renova, Retin-A, micro-dermabrasion, chemical peels) on the upper face, in the area between the eyebrows where frown lines occur, within the previous four weeks or plans to use these treatments during the study Facial or skin conditions that could interfere with treatment or confound results (e.g., signs or symptoms of eyebrow or eyelid ptosis, facial nerve palsy, scarring, infection) Implanted pacemaker or automatic implantable cardioverter/defibrillator History of keloid formation Known bleeding disorder Use of thrombolytics, anticoagulants, aspirin or non-steroidal anti-inflammatory drugs within seven days prior to study treatment Is receiving systemic corticosteroids or anabolic steroids (standard doses of inhaled or nasal corticosteroids are acceptable) History of chronic or recurrent infection, or compromised immune system Known lidocaine hypersensitivity Enrollment in another research study Pregnant, or plans to get pregnant during the follow-up period Any other condition or circumstance that might either pose a risk, in the investigator's opinion, to the subject or interfere with the ability to acquire satisfactory clinical data throughout the follow-up period

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Serene RF System<br>Percutaneous delivery of radiofrequency (RF) energy to create a temporary conduction block to the corrugator and/or procerus muscles. | Device: Serene RF System<br>* The Serene RF System provides percutaneous delivery of radiofrequency (RF) energy to a targeted nerve.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The reduction of glabellar lines | The reduction of glabellar lines will be assessed by a panel of 3 independent reviewers with expertise in dermatology and/or plastic surgery of the change in glabellar lines measured from baseline to 3, 6, 9 and 12 months post procedure. Photographs will be presented in a random order and the reviewers will be blinded to whether the photograph is baseline or a follow up. Effectiveness of the procedure is defined by a ≥ 1 point improvement in score (i.e., numerical decrease) on the Mertz Aesthetics Scale™ (Merz Scale) for dynamic glabellar lines. At each time point the severity of the glabellar lines is assessed on a 5 point scale. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of adverse events |  | 3 months | 
| The reduction of glabellar lines | The reduction of glabellar lines will be assessed by a panel of 3 independent reviewers with expertise in dermatology and/or plastic surgery of the change in glabellar lines measured from baseline to 3, 6, 9 and 12 months post procedure. Photographs will be presented in a random order and the reviewers will be blinded to whether the photograph is baseline or a follow up. Effectiveness of the procedure is defined by a ≥ 1 point improvement in score (i.e., numerical decrease) on the Mertz Aesthetics Scale™ (Merz Scale) for dynamic glabellar lines. At each time point the severity of the glabellar lines is assessed on a 5 point scale. | 12 months | 
| Subject satisfaction | Subject satisfaction will be assessed by a survey given every 3 months. This survey asks the subject questions to rate on a scale of 0-4 with 0 representing very dissatisfied and 4 representing very satisfied. | 12 months |