TriActive+ Radiofrequency (RF) for Non-Invasive Treatment of Wrinkles and Rhytides

Completed · Not applicable

Conditions studied: Wrinkles, Rhytides

In brief

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.

Key facts

Study ID

NCT01859611

Run by

El. En. SpA

People needed

51

Starts

2013-05-01

Expected to finish

2014-05-01

Last updated by the study team

2015-04-07

Who can join

Age: 30 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• ICA signed by the subject.
• Healthy male or female subjects 30-60 ys of age.
• Having at least 2 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 treat and FU schedule and the post-treat 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 study

You may not qualify if…

• Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breastfeeding. Females of childbearing potential must agree to take a urine pregnancy test (must be negative) at the Screening visit. Females of childbearing potential include anyone who has experienced menarche and who has not undergone successful surgical sterilization or is not post-menopausal for more than 2 years.
• Having any active electrical implant anywhere in the body
• Having a permanent implant in the treated area or an injected chemical substance.
• Having a history of diseases stimulated by heat unless treatment is conducted following a prophylactic regimen.
• Use of non-steroidal anti-inflammatory drugs 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 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 or collagen/Hyaluronic Acid 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 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.
• History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
• 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.
• 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 1 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.

Where it is running

• Chernoff Plastic Surgery & Laser Center — Indianapolis, Indiana, United States
• Park Avenue SmartLipo — New York, New York, United States

Full record on ClinicalTrials.gov

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