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OpenTrials
Completed

NCT Number: NCT02466178

Efficacy Trial for the Reduction of Glabellar Lines

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Premier Plastic Surgery, Palo Alto, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)
  • 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

Treatment and study plan

Serene RF System

Device

The Serene RF System provides percutaneous delivery of radiofrequency (RF) energy to a targeted nerve.

Primary outcomes

  1. The reduction of glabellar lines

    Time frame: 3 months

    The reduction of glabellar lines will be assessed by a panel of 3 independent reviewers with expertise in dermatology and/or plastic surgery of the change in glabellar lines measured from baseline to 3, 6, 9 and 12 months post procedure. Photographs will be presented in a random order and the reviewers will be blinded to whether the photograph is baseline or a follow up. Effectiveness of the procedure is defined by a ≥ 1 point improvement in score (i.e., numerical decrease) on the Mertz Aesthetics Scale™ (Merz Scale) for dynamic glabellar lines. At each time point the severity of the glabellar lines is assessed on a 5 point scale.

Secondary outcomes

  1. Incidence and severity of adverse events

    Time frame: 3 months

  2. The reduction of glabellar lines

    Time frame: 12 months

    The reduction of glabellar lines will be assessed by a panel of 3 independent reviewers with expertise in dermatology and/or plastic surgery of the change in glabellar lines measured from baseline to 3, 6, 9 and 12 months post procedure. Photographs will be presented in a random order and the reviewers will be blinded to whether the photograph is baseline or a follow up. Effectiveness of the procedure is defined by a ≥ 1 point improvement in score (i.e., numerical decrease) on the Mertz Aesthetics Scale™ (Merz Scale) for dynamic glabellar lines. At each time point the severity of the glabellar lines is assessed on a 5 point scale.

  3. Subject satisfaction

    Time frame: 12 months

    Subject satisfaction will be assessed by a survey given every 3 months. This survey asks the subject questions to rate on a scale of 0-4 with 0 representing very dissatisfied and 4 representing very satisfied.

Sponsors and collaborators

Lead sponsor

Serene Medical Inc

Industry

Registry information

Official study title

Multicenter Efficacy Trial of the Serene RF System for the Reduction of Glabellar Lines

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 9, 2015
Registry last updated
Mar 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.