Efficacy Trial for the Reduction of Glabellar Lines

Completed

Conditions studied: Rhytids in the Glabellar Region

In brief

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.

Key facts

Study ID

NCT02466178

Run by

Serene Medical Inc

People needed

78

Starts

2015-02-01

Expected to finish

2016-12-01

Last updated by the study team

2017-03-22

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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
• 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

Where it is running

• Premier Plastic Surgery — Palo Alto, California, United States
• Premier Plastic Surgery — San Mateo, California, United States
• Aesthetic Plastic Surgery — New York, New York, United States
• Reviance Plastic Surgery & Aesthetics Center — Clackamas, Oregon, United States
• Puget Sound Plastic Surgery — Kirkland, Washington, United States

Full record on ClinicalTrials.gov

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