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

NCT00612378 | Completed DMC

• 1 other identifier: ACI 09-003
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 5

Brief Summary

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).

Conditions

Glabellar Furrowing; Forehead Wrinkles

Keywords

Glabellar Furrowing

Outcome Measures

Primary Outcomes (1)

• Successful result from the GFX procedure acutely, without adverse effect

  7 to 10 days post procedure

Secondary Outcomes (1)

• Minimal or transient incidence of minor adverse events

  7 to 10 days post procedure

Study Arms (1)

1

EXPERIMENTAL

Device: GFX System

Interventions

GFX System 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.

Also known as: Radio Frequency Ablation

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Advanced Cosmetic Intervention: lead

Study Sites (5)

Premier Plastic Surgery

San Mateo, California, 94401, United States

Location

Speirs Clinic for Plastic Surgery

Colorado Springs, Colorado, 80904, United States

Location

Ben Lee, MD, LLC

Englewood, Colorado, 80113, United States

Location

David M. Knize, MD

Englewood, Colorado, 80113, United States

Location

Jasin Facial Rejuvenation

Tampa, Florida, 33613, United States

Location

MeSH Terms

Interventions

Radiofrequency Ablation

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• James Newman, M.D.

  Director, Premier Plastic Surgery; Academic - Clinical Assistant Professor, Facial Plastic & Reconstructive Surgery and Otholaryngology - Head & Neck Surgery, Stanford University Medical center/Palo Alto VA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2008
• First Posted: February 11, 2008
• Study Start: September 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: March 1, 2008
• Last Updated: June 24, 2014

Record last verified: 2014-06

Locations

US (5)