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

NCT01859611 | Completed Results

• 1 other identifier: TriActive+RF-ElEn-022013
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Wrinkles; Rhytides

Outcome Measures

Primary Outcomes (1)

• Changes to the Surface by Visual and Photographic Analysis.

  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. Each patient to be evaluated through the 9 grade Fitzpatrick Wrinkling Severity Scale. Wrinkling Score Degree of Elastosis Fine 1-3 Mild Fine to moderate 4-6 Moderate Fine to deep wrinkles 7-9 Severe

  3 Month FU

Secondary Outcomes (2)

• Patient Satisfaction and Comfort of the Treatment.

  Pre Treatment 5, 1 Week FU, 1 Month FU, 3 Month FU

• Adverse Events.

  Subjects will be followed for the duration of the study, and expected average of 20 weeks

Study Arms (1)

Radiofrequency

EXPERIMENTAL

Radiofrequency (RF) treatment with the TriActive+ RF device on the peri-oral and/or peri-orbital areas of the face once a week for eight weeks.

Device: TriActive+ RF

Interventions

TriActive+ RF DEVICE

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.

Radiofrequency

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• El. En. SpA: lead

Study Sites (2)

Chernoff Plastic Surgery & Laser Center

Indianapolis, Indiana, 46260, United States

Location

Park Avenue SmartLipo

New York, New York, 10019, United States

Location

Results Point of Contact

• Title: ALESSANDRO BIZZARRI STUDY DIRECTOR
• Organization: ELECTRONIC ENGINEERING EL.EN. SPA

A.BIZZARRI@ELEN.IT

+390558826807

Study Officials

• Alessandro Bizzari, ElEn

  El. En. SpA

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2013
• First Posted: May 22, 2013
• Study Start: May 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: May 1, 2014
• Last Updated: April 7, 2015
• Results First Posted: March 11, 2015

Record last verified: 2015-03

Locations

US (2)