Wrinkles Clinical Trial
Official title:
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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 |
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 |
NCT01859611 -
TriActive+ Radiofrequency (RF) for Non-Invasive Treatment of Wrinkles and Rhytides
|
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 |