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

NCT01460927 | Completed Results DMC

• 1 other identifier: TriActive+RF-DEKA-092011
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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)

• Fitzpatrick Classification of Wrinkling and Degree of Elastosis.

  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. Observing changes to the surface by visual and photographic analysis based on the score of 2-6 on the Fitzpatrick Classification of Wrinkling and Degree of Elastosis. (Lasers Surg Med 2003;33(4):232 42) Score Wrinkling \& Degree of Elastosis 1-3 Fine wrinkles (rhytides) and Mild Elastosis (fine textural changes with subtly accentuated skin lines) 4-6 Fine to moderate depth wrinkles, moderate number of lines and Moderate Elastosis (distinct papular elastosis \[individual papules with yellow translucency under direct lighting\] and dyschromia)

  Baseline, Pre Treatment 4, Pre Treatment 8, 1 Month FU, 3 Month FU

Study Arms (1)

TriActive+ RF

OTHER

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.

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.

TriActive+ RF

Eligibility Criteria

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

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.

Sponsors & Collaborators

• Deka Medical, Inc.: lead

Study Sites (1)

Southwest Medical Group Plastic Surgery

Vancouver, Washington, 98664, United States

Location

Results Point of Contact

• Title: Alessandro Bizzarri
• Organization: El.En. Electronic Engineering S.p.A.

a.bizzarri@elen.it

+39 055 8826807

Study Officials

• Allen Gabriel, MD

  Southwest Medical Group Plastic Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: October 24, 2011
• First Posted: October 27, 2011
• Study Start: October 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: July 4, 2014
• Results First Posted: July 4, 2014

Record last verified: 2014-06

Locations

US (1)