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

Advanced Cosmetic Intervention

Status

Completed

Conditions

Glabellar Furrowing

Forehead Wrinkles

Treatments

Device: GFX System

Study type

Interventional

Funder types

Industry

Identifiers

NCT00612378

ACI 09-003

Details and patient eligibility

About

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).

Full 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.

Enrollment

94 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.