Forehead Wrinkles, Glabellar Furrowing
Conditions
Keywords
Glabellar Furrowing
Brief summary
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
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.
Interventions
DEVICEGFX System
The GFX system employs minimally invasive technique utilizing bi-polar radio frequency (RF) technology. GFX ablates nerves activating the muscles that cause glabellar furrowing.
Sponsors
Advanced Cosmetic Intervention
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Successful result from the GFX procedure acutely, without adverse effect | 7 to 10 days post procedure |
Secondary
| Measure | Time frame |
|---|---|
| Minimal or transient incidence of minor adverse events | 7 to 10 days post procedure |
Countries
United States
Outcome results
None listed