Wrinkles Clinical Trial
Official title:
Clinical Study to Evaluate the Performance of TriActive+ RF for the Non-Invasive Treatment of Wrinkles and Rhytides
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.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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