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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Deka Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01460927
First received: October 24, 2011
Last updated: April 16, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention
Wrinkles
Rhytides
 Device: TriActive+ RF

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Study to Evaluate the Performance of TriActive+ RF for the Non-invasive Treatment of Wrinkles & Rhytides

Further study details as provided by Deka Medical, Inc.:

Primary Outcome Measures:
  • Observing changes to the surface by visual and photographic analysis. [ Time Frame: Baseline, Pre Treatment 4, Pre Treatment 8, 1 Month FU, 3 Month FU ] [ Designated as safety issue: No ]
    At each of the specified time points, photographs of the treated areas will be taken. The photography angles will include a global frontal photo and the right and left sides of the face at 45° and/or 90°. In addition, close up photos will be taken of specific facial zones, e.g., the peri orbital wrinkles.


Enrollment: 25
Study Start Date: October 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: TriActive+ RF
    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.
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. 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.

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  • History of keloid scarring or of abnormal wound healing.
  • Suffering from current or history of significant skin conditions in the treated area or inflammatory skin conditions, including, but not limited to: excessive skin dryness, psoriasis, eczema, rash, rosacea (particularly severe open wound stage), indurate acne, varicella scars, open lacerations or abrasions and active cold sores or herpes sores prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatment course.
  • History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
  • History of epidermal or dermal disorders (particularly if involving collagen or microvascularity).
  • History of pigmentary disorders, particularly tendency for hyper- or hypopigmentation.
  • Suffering from hormonal imbalance, as per the Investigator's discretion.
  • Having a known anticoagulative or thromboembolic condition or taking anticoagulation medications one week prior to and during the treatment course (to allow inclusion, temporary cessation of use as per the subject's physician discretion).
  • Having or undergoing any form of treatment for active cancer, or having a history of skin cancer or any other cancer in the areas to be treated, including presence of malignant or pre-malignant pigmented lesions.
  • Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), or pertinent neurological disorders.
  • Vascular lesion, tattoo or permanent make-up in the treated area.
  • Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
  • Participation in a study of another device or drug within one month prior to enrollment or during the study.
  • As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01460927

Locations
United States, Washington
Southwest Medical Group Plastic Surgery
Vancouver, Washington, United States, 98664
Sponsors and Collaborators
Deka Medical, Inc.
Investigators
Principal Investigator: Allen Gabriel, MD Southwest Medical Group Plastic Surgery
  More Information

No publications provided

Responsible Party: Deka Medical, Inc.
ClinicalTrials.gov Identifier: NCT01460927     History of Changes
Other Study ID Numbers: TriActive+RF-DEKA-092011
Study First Received: October 24, 2011
Last Updated: April 16, 2012
Health Authority: United States: PeaceHealth Southwest Medical Center Surgery Department

ClinicalTrials.gov processed this record on June 13, 2013