Glabellar FurrowingPhase 4NCT00611273
A Multi-center Long Term Efficacy Trial of the GFX For Reduction of Glabellar Furrowing
A Phase 4 study testing GFX in people with Glabellar Furrowing, run by Advanced Cosmetic Intervention at 10 sites in 2 countries.
Trial summary
Long term efficacy study of GFX for patients undergoing reduction of glabellar furrowing 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
- What is being tested?
- GFX
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Sep 2007to Apr 2008
- Phase
- Phase 4
- 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
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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 locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States9 sites
Foad Nahai, M.D., F.A.C.S.
Atlanta, Georgia, 30327
Paul S. Nassif, MD, FACS
Beverly Hills, California, 90212
J. Smythe Rich, III, M.D
Columbia, South Carolina, 29203
Steven P. Block, MD
Highland Park, Illinois, 60035
Russell W. Kridel, MD
Houston, Texas, 77030
Roger C. Mixter, MD
Milwaukee, Wisconsin, 53217
James Newman
San Mateo, California, 94401
Keith LaFerriere, MD
Springfield, Missouri, 65807
Michael E. Jansin, MD
Tampa, Florida, 33613
About this study
Long term efficacy study of GFX for patients undergoing reduction of glabellar furrowing
Read the detailed description
A Multi-center Long Term Efficacy Trial of GFX for the Reduction of Glabellar Furrowing
- Conditions
- Glabellar Furrowing
- Being tested
- GFX
- Keywords
- Glabellar Furrowing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GFXDevice
Also called RF Nerve Ablation 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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 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. Receives: Device: GFX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time at which the patient no longer shows an improvement from the base line RNKLS score indicating that the initially successful GFX procedure is no longer effective at a scheduled follow-up visit.
Measured: 18 months
Secondary outcomes (1)
Minimal or transient incidence of minor unanticipated adverse events.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2008 (estimated)
- Study startSep 2007
- Primary completionApr 2008
- Study completionApr 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Cosmetic Intervention
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Newman, MD, Study director, Premier Plastic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00611273
- Sponsor's protocol ID
- ACI 007-02
- Other IDs
- WIRB 20062119
- Status last verified
- Jun 2014
- First submitted
- 28 Jan 2008
- Last updated
- 24 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
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 Long Term Efficacy Trial of the GFX For Reduction of Glabellar Furrowing
- ClinicalTrials.gov ID
- NCT00611273
- Acronym / sponsor ID
- ACI 007-02
- Conditions
- Glabellar Furrowing
- Keywords
- Glabellar Furrowing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Advanced Cosmetic InterventionIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 8 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.
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
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: GFXPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
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 |
|---|---|---|
| GFXAlso: RF Nerve Ablation DeviceThe 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
Time at which the patient no longer shows an improvement from the base line RNKLS score indicating that the initially successful GFX procedure is no longer effective at a scheduled follow-up visit.
Time frame: 18 months
1 secondary outcome
Minimal or transient incidence of minor unanticipated adverse events.
Time frame: 30 days
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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Wrinkle, Glabellar Frown Lines
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, MD study director
Premier Plastic Surgery
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing GFX in people with Glabellar Furrowing, run by Advanced Cosmetic Intervention at 10 sites in 2 countries.
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 7 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 10 sites in United States, Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time at which the patient no longer shows an improvement from the base line RNKLS score indicating that the initially successful GFX procedure is no longer effective at a scheduled follow-up visit. (time frame: 18 months). 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.