Trial Outcomes & Findings for TriActive+ Radiofrequency (RF) for Non-invasive Treatment of Wrinkles & Rhytides (NCT NCT01460927)

Results Overview

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)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

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

Results posted on

2014-07-04

Participant Flow

Participant milestones

Participant milestones
Measure	TriActive+RF Subjects will receive up to 8 treatments on at least two facial sub areas (e.g., left peri-orbital, right peri-orbital and/or peri-oral). Treatments will be administered once a week (±2days) with evaluation follow-up visits at one (1) week (±2days), one (1) month (±4days), and three (3) months (±4days) following the final treatment. The treatments start at a low power (3W for the small tip, 10W for the medium and large tips) and then gradually increase the setting up to the highest powers available within the tips, checking the subject's tolerability and reaction of the tissue. The power is adjusted to suit the subject's sensitivity and the "depth" of tissue to be treated (deeper tissue requires the larger tip). The goal is to progressively and smoothly reach an epidermal temperature end-point of 43°C. The treatment end-point correlates directly with the measurement of the skin temperature. The temperature of 43°C should be maintained at the end point for several minutes (3-5min).
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TriActive+ RF n=25 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	49 years STANDARD_DEVIATION 7.4 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants

PRIMARY outcome

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

Population: Per protocol

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)

Outcome measures

Outcome measures
Measure	Baseline n=25 Participants Baseline (before Treatments)	Pre Treatment 4 n=25 Participants After 3 treatments	Pre Treatment 8 n=25 Participants After 7 treatments	1 Month FU n=25 Participants 1 Month after the 8th treatment	3 Month FU n=25 Participants 3 Months after the 8th treatment
Fitzpatrick Classification of Wrinkling and Degree of Elastosis.	5.6 Fitzpatrick Classification Scale Full Range 1 • Interval 1.0 to 6.0	5.56 Fitzpatrick Classification Scale Full Range 2 • Interval 1.0 to 6.0	5.36 Fitzpatrick Classification Scale Interval 1.0 to 6.0	5.32 Fitzpatrick Classification Scale Interval 1.0 to 6.0	4.88 Fitzpatrick Classification Scale Interval 1.0 to 6.0

Adverse Events

TriActive+RF

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	TriActive+RF n=25 participants at risk Subjects will receive up to 8 treatments with the TriActive+ RF on at least two facial sub areas (e.g., left peri-orbital, right peri-orbital and/or peri-oral). Treatments will be administered once a week (±2 days).
Skin and subcutaneous tissue disorders Irritation, itching, erythema, edema	4.0% 1/25 • Number of events 1 • 1 year

Additional Information

Alessandro Bizzarri

El.En. Electronic Engineering S.p.A.

Phone: +39 055 8826807

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Investigator shall have the right to publish the results of the Trial provided Sponsor has given it prior written approval. Sponsor reserves the right to remove all Confidential Information from any communications, or if Sponsor deems that such removal does not sufficiently protect its intellectual property rights, to require that Investigator refrain from making such communications.
Publication restrictions are in place

Restriction type: OTHER