This trial is active, not recruiting.

Condition rhytids in the glabellar region
Treatment serene rf system
Sponsor Serene Medical Inc
Start date February 2015
End date April 2016
Trial size 78 participants
Trial identifier NCT02466178, SM 14-01


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Percutaneous delivery of radiofrequency (RF) energy to create a temporary conduction block to the corrugator and/or procerus muscles.
serene rf system
The Serene RF System provides percutaneous delivery of radiofrequency (RF) energy to a targeted nerve.

Primary Outcomes

The reduction of glabellar lines
time frame: 3 months

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

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title Multicenter Efficacy Trial of the Serene RF System for the Reduction of Glabellar Lines
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Serene Medical Inc.