Rhytids in the Glabellar RegionNCT02466178
Efficacy Trial for the Reduction of Glabellar Lines
An observational study of Rhytids in the Glabellar Region, run by Serene Medical Inc at 5 sites in United States.
Trial summary
The purpose of this study is to evaluate the ability of the Serene RF System to effectively improve the appearance of dynamic glabellar lines and sustain the effect for a minimum of 3 months. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Rhytids in the Glabellar Region
- What is being tested?
- Serene RF System
- Type of treatment
- Medical device
- How many people
- 78 participants
- Where
- 5 sitesUnited States
- Study dates
- Feb 2015to Dec 2016
- Phase
- Observational
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult men and women with moderate to severe glabellar lines
Who may be able to join
- Glabellar lines rating of at least two per the Merz Scale
- Written informed consent
- Understands and accepts the following obligations during the follow-up period (minimum of three months and up to one year)
- available for the 3 day phone call and present for each follow-up visit;
- receive NO other facial procedures in the upper face for a minimum of three months and up to one year after the RF procedure;
- make NO changes to the eyebrows for a minimum of three months after the RF procedure.
Who cannot join
- Injection of botulinum toxin to the upper face within the previous four months
- Use of fillers in the upper face within the previous twelve months
- Use of prescription treatments (e.g., Renova, Retin-A, micro-dermabrasion, chemical peels) on the upper face, in the area between the eyebrows where frown lines occur, within the previous four weeks or plans to use these treatments during the study
- Facial or skin conditions that could interfere with treatment or confound results (e.g., signs or symptoms of eyebrow or eyelid ptosis, facial nerve palsy, scarring, infection)
- Implanted pacemaker or automatic implantable cardioverter/defibrillator
- History of keloid formation
Show all 13Show fewer
- Known bleeding disorder
- Use of thrombolytics, anticoagulants, aspirin or non-steroidal anti-inflammatory drugs within seven days prior to study treatment Is receiving systemic corticosteroids or anabolic steroids (standard doses of inhaled or nasal corticosteroids are acceptable)
- History of chronic or recurrent infection, or compromised immune system
- Known lidocaine hypersensitivity
- Enrollment in another research study
- Pregnant, or plans to get pregnant during the follow-up period
- Any other condition or circumstance that might either pose a risk, in the investigator's opinion, to the subject or interfere with the ability to acquire satisfactory clinical data throughout the follow-up period
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Reviance Plastic Surgery & Aesthetics Center
Clackamas, Oregon, 97015
Puget Sound Plastic Surgery
Kirkland, Washington, 98033
Aesthetic Plastic Surgery
New York, New York, 10025
Premier Plastic Surgery
Palo Alto, California, 94306-3811
Premier Plastic Surgery
San Mateo, California, 94401
About this study
Official title: Multicenter Efficacy Trial of the Serene RF System for the Reduction of Glabellar Lines
The purpose of this study is to evaluate the ability of the Serene RF System to effectively improve the appearance of dynamic glabellar lines and sustain the effect for a minimum of 3 months.
- Conditions
- Rhytids in the Glabellar Region
- Being tested
- Serene RF System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serene RF SystemDevice
The Serene RF System provides percutaneous delivery of radiofrequency (RF) energy to a targeted nerve.
| Study group | Role | What they receive |
|---|---|---|
| Serene RF System | Percutaneous delivery of radiofrequency (RF) energy to create a temporary conduction block to the corrugator and/or procerus muscles. Receives: Device: Serene RF System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The reduction of glabellar lines
The reduction of glabellar lines will be assessed by a panel of 3 independent reviewers with expertise in dermatology and/or plastic surgery of the change in glabellar lines measured from baseline to 3, 6, 9 and 12 months post procedure. Photographs will be presented in a random order and the reviewers will be blinded to whether the photograph is baseline or a follow up. Effectiveness of the procedure is defined by a ≥ 1 point improvement in score (i.e., numerical decrease) on the Mertz Aesthetics Scale™ (Merz Scale) for dynamic glabellar lines. At each time point the severity of the glabellar lines is assessed on a 5 point scale.
Measured: 3 months
Secondary outcomes (3)
Incidence and severity of adverse events
Measured: 3 months
The reduction of glabellar lines
The reduction of glabellar lines will be assessed by a panel of 3 independent reviewers with expertise in dermatology and/or plastic surgery of the change in glabellar lines measured from baseline to 3, 6, 9 and 12 months post procedure. Photographs will be presented in a random order and the reviewers will be blinded to whether the photograph is baseline or a follow up. Effectiveness of the procedure is defined by a ≥ 1 point improvement in score (i.e., numerical decrease) on the Mertz Aesthetics Scale™ (Merz Scale) for dynamic glabellar lines. At each time point the severity of the glabellar lines is assessed on a 5 point scale.
Measured: 12 months
Subject satisfaction
Subject satisfaction will be assessed by a survey given every 3 months. This survey asks the subject questions to rate on a scale of 0-4 with 0 representing very dissatisfied and 4 representing very satisfied.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study startFeb 2015
- Primary completionApr 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhytids in the Glabellar RegionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Serene Medical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott McGill, Study director, Vice President Product Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02466178
- Sponsor's protocol ID
- SM 14-01
- Status last verified
- Mar 2017
- First submitted
- 11 Mar 2015
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Efficacy Trial of the Serene RF System for the Reduction of Glabellar Lines
- ClinicalTrials.gov ID
- NCT02466178
- Acronym / sponsor ID
- SM 14-01
- Conditions
- Rhytids in the Glabellar Region
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Serene Medical IncIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 9 Jun 2015 (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 study is to evaluate the ability of the Serene RF System to effectively improve the appearance of dynamic glabellar lines and sustain the effect for a minimum of 3 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Serene RF System | – | Device: Serene RF SystemPercutaneous delivery of radiofrequency (RF) energy to create a temporary conduction block to the corrugator and/or procerus muscles. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult men and women with moderate to severe glabellar lines
Key inclusion criteria (6 listed)
- Glabellar lines rating of at least two per the Merz Scale
- Written informed consent
- Understands and accepts the following obligations during the follow-up period (minimum of three months and up to one year)
- available for the 3 day phone call and present for each follow-up visit;
- receive NO other facial procedures in the upper face for a minimum of three months and up to one year after the RF procedure;
Key exclusion criteria (13 listed)
- Injection of botulinum toxin to the upper face within the previous four months
- Use of fillers in the upper face within the previous twelve months
- Use of prescription treatments (e.g., Renova, Retin-A, micro-dermabrasion, chemical peels) on the upper face, in the area between the eyebrows where frown lines occur, within the previous four weeks or plans to use these treatments during the study
- Facial or skin conditions that could interfere with treatment or confound results (e.g., signs or symptoms of eyebrow or eyelid ptosis, facial nerve palsy, scarring, infection)
- Implanted pacemaker or automatic implantable cardioverter/defibrillator
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 |
|---|---|---|
| Serene RF SystemThe Serene RF System provides percutaneous delivery of radiofrequency (RF) energy to a targeted nerve. | Device | Serene RF System |
Primary outcome
The reduction of glabellar lines
Time frame: 3 months
The reduction of glabellar lines will be assessed by a panel of 3 independent reviewers with expertise in dermatology and/or plastic surgery of the change in glabellar lines measured from baseline to 3, 6, 9 and 12 months post procedure. Photographs will be presented in a random order and the reviewers will be blinded to whether the photograph is baseline or a follow up. Effectiveness of the procedure is defined by a ≥ 1 point improvement in score (i.e., numerical decrease) on the Mertz Aesthetics Scale™ (Merz Scale) for dynamic glabellar lines. At each time point the severity of the glabellar lines is assessed on a 5 point scale.
3 secondary outcomes
Incidence and severity of adverse events
Time frame: 3 months
The reduction of glabellar lines
Time frame: 12 months
Subject satisfaction
Time frame: 12 months
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 22 Mar 2017.
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.
Scott McGill study director
Vice President Product Development
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhytids in the Glabellar Region, run by Serene Medical Inc 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 13 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 22 Mar 2017. 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?
The reduction of glabellar lines (time frame: 3 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 22 Mar 2017.