Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01859611
Study type Interventional
Source El. En. SpA
Contact
Status Completed
Phase N/A
Start date May 2013
Completion date May 2014

See also
  Status Clinical Trial Phase
Completed NCT01984619 - Prospective Study Evaluating the Treatment of Hyperdynamic Forehead Wrinkles N/A
Completed NCT01713985 - Feasibility Study: Evaluation of Ulthera Versus Thermage for Treating the Face and Neck N/A
Recruiting NCT01586819 - Lateral Canthal Rhytides With Medium Depth Chemical Peel With or Without Pretreatment With Botulinum Toxin A Phase 3
Completed NCT05254210 - Feasibility Study To Collect Safety And Preliminary Efficacy Data For A Radiofrequency Microneedling Device N/A
Completed NCT02604641 - Assessment of the Impact of a Coenzyme Q10 Supplementation on the Skin N/A
Completed NCT01519934 - A Retrospective Study to Evaluate the Effectiveness of the Ulthera System N/A
Completed NCT01460927 - TriActive+ Radiofrequency (RF) for Non-invasive Treatment of Wrinkles & Rhytides N/A
Completed NCT03811756 - The Effect of 12-week Dietary Intake of Syrup Containing CoQ10 and Collagen on Dermis Density and Other Skin Parameters N/A
Completed NCT04988412 - The Effect of 12-week Dietary Intake of Food Supplements Containing Collagen on Dermis Density and Other Skin Parameters N/A
Completed NCT02913547 - Silk'n HST for Wrinkle Reduction - Clinical Study Protocol N/A
Active, not recruiting NCT02019004 - A Pilot Study Testing Onabotulinum Toxin A Versus Incobotulinum Toxin A Injections for Facial Wrinkles N/A
Completed NCT02340078 - A Clinical Study to Evaluate the Efficacy and Safety of YVOIRE Volume Plus Versus YVOIRE Volume in Nasolabial Fold Injection N/A
Completed NCT01283464 - Comparison of Retinol 1.0% and Tretinoin 0.02% in the Treatment of Moderate to Severe Photodamage and Wrinkles Phase 2
Completed NCT01034956 - Outcomes and Patient Experience After Soft Tissue Dermal Filler Injections N/A
Completed NCT02425943 - Sculptra Aesthetic Post-Approval Study Phase 4
Recruiting NCT05847530 - Pilot Evaluation of the Cynosure Potenza™ System for Treatment of Cosmetic Dermatologic Skin Conditions N/A
Enrolling by invitation NCT01847066 - Epidermal Delivery of Ani-Aging Ingredients N/A
Completed NCT01297634 - Radial Diffusion of the Botulinum Toxin Type A (Botox®): Electromyographic Evaluation of the Frontal Muscle Phase 4
Completed NCT05011461 - The Effect of Topical Almond Oil vs. Topical Retinol on The Appearance of Facial Wrinkles N/A
Completed NCT03460860 - Astaxanthin (2 mg) + Lycopene (1.8 mg) + D-Alpha-Tocopherol (10 IU) For The Treatment Of Skin Aging N/A