A Multi-center Acute Efficacy Trial of GFX For Reduction of Glabellar Furrowing

Study Overview
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Brief Summary
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The purpose of this research study is to evaluate the immediate effectiveness of the GFX™ device in reducing the furrows (deep frown lines) between eyebrows (glabellar region).

Detailed Description
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The purpose of this research study is to evaluate the acute ability of GFX to reduce glabellar furrowing. Patients who have presented to the investigator for correction of glabellar furrows, as classified per the Rated Numeric Kinetic Line Scale Score for Facial Wrinkles Secondary to Hyperkinetic Function (Note: Class 1 or Higher)7 (Appendix N) are candidates for this study. All patients must consent to the procedure and agree to complete their post treatment evaluation visit.

Official Title
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A Multi-center Acute Efficacy Trial of GFX For Reduction of Glabellar Furrowing

Conditions
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Glabellar Furrowing, Forehead Wrinkles

Intervention / Treatment
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* Device: GFX System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has no medical contraindication Presenting for correction of glabellar furrows, as classified per the Rated Numeric Kinetic Line Scale Score for Facial Wrinkles Secondary to Hyperkinetic Function (Class 1 or Higher) are candidates for this study Is at least 18 years of age Signs a written informed consent Understands and accepts the obligation to present for the scheduled follow-up visit Understands that the GFX procedure may not be successful. Exclusion Criteria: Has had an injection of botulinum toxin to the target area within the previous 3 months and still exhibits a positive cosmetic effect to the glabellar furrow Has had silicone, fat, collagen or a synthetic material placed in the glabellar region or surgical correction or excision of the glabellar furrows Has a known bleeding disorder Has received or is anticipated to receive anti-platelets, anti-coagulants thrombolytics or cancer therapy Is receiving systemic corticosteroids or anabolic steroids (standard doses of inhaled or nasal corticosteroids are acceptable) Has a history of chronic or recurrent infection or compromised immune system Has severe allergies manifested by a history of anaphylaxis Has known lidocaine hypersensitivity Is enrolled in another study Is Pregnant Has history of keloid formation The investigator believes the patient is not a suitable candidate for the GFX procedure, or is not likely to receive cosmetic benefit.

Ages Eligible for Study
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Minimum Age: 18 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: 1<br> | Device: GFX System<br>* The GFX system employs minimally invasive technique utilizing bi-polar radio frequency (RF) technology. GFX ablates nerves activating the muscles that cause glabellar furrowing.<br>* Other names: Radio Frequency Ablation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful result from the GFX procedure acutely, without adverse effect |  | 7 to 10 days post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal or transient incidence of minor adverse events |  | 7 to 10 days post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glabellar Furrowing