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

NCT ID: NCT00611273

Last Updated: 2014-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2008-04-30

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

Conditions

Glabellar Furrowing

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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.

Group Type: EXPERIMENTAL

GFX

Intervention Type: DEVICE

The GFX system employs minimally invasive technique utilizing Bi-polar (radio frequency) RF technology. GFX ablates nerves activating the muscles that cause glabellar furrowing.

Interventions

GFX

The GFX system employs minimally invasive technique utilizing Bi-polar (radio frequency) RF technology. GFX ablates nerves activating the muscles that cause glabellar furrowing.

Intervention Type: DEVICE

Other Intervention Names

RF Nerve Ablation Device

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Advanced Cosmetic Intervention

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Newman, MD

Role: STUDY_DIRECTOR

Premier Plastic Surgery

Locations

Paul S. Nassif, MD, FACS

Beverly Hills, California, United States

James Newman

San Mateo, California, United States

Michael E. Jansin, MD

Tampa, Florida, United States

Foad Nahai, M.D., F.A.C.S.

Atlanta, Georgia, United States

Steven P. Block, MD

Highland Park, Illinois, United States

Keith LaFerriere, MD

Springfield, Missouri, United States

J. Smythe Rich, III, M.D

Columbia, South Carolina, United States

Russell W. Kridel, MD

Houston, Texas, United States

Roger C. Mixter, MD

Milwaukee, Wisconsin, United States

David A. Ellis, MD

Toronto, Ontario, Canada

Countries

United States; Canada

Other Identifiers

WIRB 20062119

Identifier Type: -

Identifier Source: secondary_id

ACI 007-02

Identifier Type: -

Identifier Source: org_study_id