Glabellar FurrowingNCT00612378
A Multi-center Acute Efficacy Trial of GFX For Reduction of Glabellar Furrowing
A study testing GFX System in people with Glabellar Furrowing and Forehead Wrinkles, run by Advanced Cosmetic Intervention at 5 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glabellar Furrowing, Forehead Wrinkles
- What is being tested?
- GFX System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 5 sitesUnited States
- Study dates
- Sep 2007to Mar 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Speirs Clinic for Plastic Surgery
Colorado Springs, Colorado, 80904
Ben Lee, MD, LLC
Englewood, Colorado, 80113
David M. Knize, MD
Englewood, Colorado, 80113
Premier Plastic Surgery
San Mateo, California, 94401
Jasin Facial Rejuvenation
Tampa, Florida, 33613
About this study
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).
Read the detailed description
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
- Glabellar Furrowing, Forehead Wrinkles
- Being tested
- GFX System
- Keywords
- Glabellar Furrowing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GFX SystemDevice
Also called Radio Frequency Ablation
The GFX system employs minimally invasive technique utilizing bi-polar radio frequency (RF) technology. GFX ablates nerves activating the muscles that cause glabellar furrowing.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Device: GFX System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful result from the GFX procedure acutely, without adverse effect
Measured: 7 to 10 days post procedure
Secondary outcomes (1)
Minimal or transient incidence of minor adverse events
Measured: 7 to 10 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2008 (estimated)
- Study startSep 2007
- Primary completionFeb 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glabellar FurrowingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Cosmetic Intervention
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Newman, M.D., 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00612378
- Sponsor's protocol ID
- ACI 09-003
- Status last verified
- Jun 2014
- First submitted
- 18 Jan 2008
- Last updated
- 24 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Acute Efficacy Trial of GFX For Reduction of Glabellar Furrowing
- ClinicalTrials.gov ID
- NCT00612378
- Acronym / sponsor ID
- ACI 09-003
- Conditions
- Glabellar Furrowing, Forehead Wrinkles
- Keywords
- Glabellar Furrowing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Advanced Cosmetic InterventionIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 11 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: GFX System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GFX SystemAlso: Radio Frequency AblationThe GFX system employs minimally invasive technique utilizing bi-polar radio frequency (RF) technology. GFX ablates nerves activating the muscles that cause glabellar furrowing. | Device | 1 |
Primary outcome
Successful result from the GFX procedure acutely, without adverse effect
Time frame: 7 to 10 days post procedure
1 secondary outcome
Minimal or transient incidence of minor adverse events
Time frame: 7 to 10 days post procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Newman, M.D. 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
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GFX System in people with Glabellar Furrowing and Forehead Wrinkles, run by Advanced Cosmetic Intervention at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful result from the GFX procedure acutely, without adverse effect (time frame: 7 to 10 days post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2014.