TriActive+ Radiofrequency (RF) for Non-Invasive Treatment of Wrinkles and Rhytides
Condition: Wrinkles; Rhytides
Study type: Interventional

Summary: 
      The study objective is to evaluate the safety and efficacy of a radiofrequency (RF) source,
      the TriActive+ RF handpiece, for treatment of wrinkles and rhytides after multiple
      treatments. The primary endpoint is observation of changes to the surface by visual and
      photographic analysis. Secondary endpoints: measurement of patient satisfaction and comfort
      of the treatment and the measurement of adverse events.
    

Detailed description: 
      Collagen varies genetically and structurally. Collagen breakdown increases with chronological
      age and photoaging. While fibroblasts normally replace damaged collagen fibers with new ones,
      the ability of fibroblasts to replace collagen is compromised by natural aging and
      environmental stress. Although collagen fibers form a loose interlacing network that is
      deformable, increased collagen breakdown leads to thinning and loss of the elastic fiber
      network in the dermis. This breakdown results in the formation of wrinkles, especially in
      areas of the skin exposed to the sun, which are most prone to wrinkles and imperfections.
      Nonablative dermal remodeling has gained tremendous popularity among patients and
      practitioners, offering a low incidence of adverse effects and modest improvement in the
      various signs of cutaneous photoaging, including rhytides, dyschromias and telangiectasias.
      Controlled thermal skin injury has been shown to effect a conformational change in the
      structure and length of collagen and may also induce fibroblast response for long-term
      collagen remodeling. Interest in utilizing radiofrequency energy to enhance deep tissue
      tightening and thus improve skin laxity has grown, as radiofrequency energy has been shown in
      multiple studies to tighten tissue, producing a noticeable skin lifting.

      This study is intended to evaluate the clinical performance of a radiofrequency (RF) source
      as engendered in the TriActive+ RF for the non-invasive treatment of wrinkles and rhytides.

      Eligible subjects who have signed an ICF will receive up to 8 treatments on at least two
      facial sub areas (left peri-orbital, right peri-orbital and peri-oral). Up to 25 subjects
      will be enrolled in the study at two sites. Treatments will start at a low power and then
      gradually increase, based on tolerability and tissue reaction. The goal is to progressively
      reach and maintain an epidermal temperature end-point. The site will use an IR thermometer to
      ensure the rise in temperature does not exceed 43° C.

      Treatments will be once a week with follow-up visits at one week, one month, and three months
      following the final treatment. Clinical assessments by the investigator and digital
      photographs will be taken prior to the baseline treatment, immediately prior to the 5th
      treatment, and at the 1 week, 1 month and 3 month follow-up visits.
    

Intervention name(s): TriActive+ RF
Intervention type(s): Device
Intervention description(s): Radio frequency handpiece uses a multi-polar technology with a particular electrical frequency of 1MHz. The handpiece has a special "skin contact identification" system which delivers energy only when electrodes are adherent to the skin surface in order to avoid the prickling sensation when the treatment starts.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment