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

NCT01460927

Run by

Deka Medical, Inc.

People needed

25

Starts

2011-10-01

Expected to finish

2012-04-01

Last updated by the study team

2014-07-04

Who can join

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

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Southwest Medical Group Plastic Surgery — Vancouver, Washington, United States

Full record on ClinicalTrials.gov

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