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

Advanced Cosmetic Intervention

Status and phase: Completed; Phase 4

Conditions: Glabellar Furrowing

Treatments: Device: GFX

Study type: Interventional

Funder types: Industry

Identifiers

NCT00611273

ACI 007-02

WIRB 20062119

Details and patient eligibility

About

Long term efficacy study of GFX for patients undergoing reduction of glabellar furrowing

Full description

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

Enrollment: 260 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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260 participants in 1 patient group

1

Experimental group

Description:

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 R) are candidates for this study.

Treatment:

Device: GFX