TriActive+ Radiofrequency (RF) for Non-invasive Treatment of Wrinkles & Rhytides

Clinical Study to Evaluate the Performance of TriActive+ RF for the Non-invasive Treatment of Wrinkles & 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. 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 42° 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 4th and 8th treatment, and at the 1 month and 3 month follow-up visits.

Inclusion Criteria:

• Informed consent agreement signed by the subject.
• Healthy male or female subjects 30-60 years of age.
• Having at least two facial sub-areas (left peri-orbital, right peri-orbital or peri-oral) with visible lines/wrinkles and elastosis, which correlate to a score of 2-6 on the Fitzpatrick Classification of Wrinkling and Degree of Elastosis.
• Willingness to follow the treatment and follow-up schedule and the post-treatment care.
• For female candidates - post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study (i.e., oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide, or abstinence).

Exclusion Criteria:

• Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breastfeeding.
• Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
• Having a permanent implant in the treated area, such as metal plates and screws, or an injected chemical substance.
• Having a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treated area, unless treatment is conducted following a prophylactic regimen.
• Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g., ibuprofen-containing agents) one week before and after each treatment session.
• Use of retinoids, antioxidants or skin nourishing supplements within 1 month of treatment or during the study.
• Having received a facial within 1 month of treatment or during the study.
• Having received a facial dermabrasion or chemical peel treatment within 2 months of treatment or during the study.
• Having received treatment with light, RF or other devices in the treated area within 6 months of treatment or during the study.
• Having received Botox in the treated area within 6 months of treatment or during the study.
• Having received collagen/Hyaluronic Acid (HA) in the treated area within a year of treatment or during the study.
• Having undergone a resurfacing procedure, face lift or eyelid surgery within a year of treatment or during the study.
• Having undergone any other surgery in the treated area within 6 months of treatment (or more if skin has not healed completely) or during the study.
• Having ever received fat injections or other methods of augmentation with injected or implanted material in the treated area or planning to during the study.