Glabellar Furrowing
Conditions
Keywords
Glabellar Furrowing
Brief summary
Long term efficacy study of GFX for patients undergoing reduction of glabellar furrowing
Detailed description
A Multi-center Long Term Efficacy Trial of GFX for the Reduction of Glabellar Furrowing
Interventions
DEVICEGFX
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
The patient will be included if: * Has no medical contraindication * Presents 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) * Is at least 18 years of age * Signs a written informed consent * Understands and accepts the obligation to present for scheduled follow-up visits * Understands that the GFX procedure may not be successful * Presents at the one month follow-up visit with an improvement from the base line RNKLS score
Exclusion criteria
The patient will be excluded if: * Has had an injection of botulinum toxin to the target area within the previous 4 months and still exhibits a positive cosmetic effect to the glabellar frown. * 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 * Pregnant * 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 * 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 benefitPresents at the one month follow-up visit with no improvement from the base line RNKLS score
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time at which the patient no longer shows an improvement from the base line RNKLS score indicating that the initially successful GFX procedure is no longer effective at a scheduled follow-up visit. | 18 months |
Secondary
| Measure | Time frame |
|---|---|
| Minimal or transient incidence of minor unanticipated adverse events. | 30 days |
Countries
Canada, United States
Outcome results
None listed