A Multi-center Long Term Efficacy Trial of the GFX For Reduction of Glabellar Furrowing

Exclusion Criteria

• •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