CompletedNot Applicable

Efficacy Trial for the Reduction of Glabellar Lines

United States78 participantsStarted 2015-02

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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)

What they're measuring

The reduction of glabellar lines

Timeframe: 3 months

Trial details

NCT IDNCT02466178

SponsorSerene Medical Inc

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2016-04

View on ClinicalTrials.gov More Rhytids in the Glabellar Region trials