Efficacy Trial for the Reduction of Glabellar Lines

Serene Medical

Status: Completed

Conditions: Rhytids in the Glabellar Region

Treatments: Device: Serene RF System

Study type: Observational

Funder types: Industry

Identifiers

NCT02466178

SM 14-01

Details and patient eligibility

About

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.

Enrollment: 78 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

78 participants in 1 patient group

Serene RF System

Description:

Percutaneous delivery of radiofrequency (RF) energy to create a temporary conduction block to the corrugator and/or procerus muscles.

Treatment:

Device: Serene RF System