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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-03-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Glabellar Furrowing Forehead Wrinkles

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

GFX System

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

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GFX System

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

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Radio Frequency Ablation

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James Newman, M.D.

Role: STUDY_DIRECTOR

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