Clinical trial NCT02466178: Efficacy Trial for the Reduction of Glabellar Lines
Official title: Multicenter Efficacy Trial of the Serene RF System for the Reduction of Glabellar Lines
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhytids in the Glabellar Region
Lead sponsor: Serene Medical Inc
Sponsor class: INDUSTRY
First posted: 2015-06-09
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult men and women with moderate to severe glabellar lines

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Glabellar lines rating of at least two per the Merz Scale
2. Written informed consent
3. Understands and accepts the following obligations during the follow-up period (minimum of three months and up to one year)
4. available for the 3 day phone call and present for each follow-up visit;
5. receive NO other facial procedures in the upper face for a minimum of three months and up to one year after the RF procedure;
6. make NO changes to the eyebrows for a minimum of three months after the RF procedure.

Exclusion Criteria:

1. Injection of botulinum toxin to the upper face within the previous four months
2. Use of fillers in the upper face within the previous twelve months
3. 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
4. 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)
5. Implanted pacemaker or automatic implantable cardioverter/defibrillator
6. History of keloid formation
7. Known bleeding disorder
8. 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)
9. History of chronic or recurrent infection, or compromised immune system
10. Known lidocaine hypersensitivity
11. Enrollment in another research study
12. Pregnant, or plans to get pregnant during the follow-up period
13. 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

Primary outcomes:
measure: The reduction of glabellar lines
timeFrame: 3 months
Secondary outcomes:
measure: Incidence and severity of adverse events
timeFrame: 3 months
measure: The reduction of glabellar lines
timeFrame: 12 months
measure: Subject satisfaction
timeFrame: 12 months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Premier Plastic Surgery
state: California
city: San Mateo
country: United States
facility: Premier Plastic Surgery
state: California
city: New York
country: United States
facility: Aesthetic Plastic Surgery
state: New York
city: Clackamas
country: United States
facility: Reviance Plastic Surgery & Aesthetics Center
state: Oregon
city: Kirkland
country: United States
facility: Puget Sound Plastic Surgery
state: Washington
Study officials:
affiliation: Vice President Product Development
name: Scott McGill
role: STUDY_DIRECTOR
References: