Trial Outcomes & Findings for TriActive+ Radiofrequency (RF) for Non-Invasive Treatment of Wrinkles and Rhytides (NCT NCT01859611)

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. 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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

51 participants

Primary outcome timeframe

3 Month FU

Results posted on

2015-04-07

Participant Flow

recruitment period from April 2013 to August 2013 at two private offices

Participant milestones

Participant milestones
Measure	Radiofrequency 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. TriActive+ RF: 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.
Overall Study STARTED	51
Overall Study COMPLETED	43
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Radiofrequency n=51 Participants 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. TriActive+ RF: 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	51 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	45 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United States	51 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 Month FU

Population: Number of participants with observed changes (grade of improvement ≥ 1) to the surface of the skin based on photographic analysis at 3 Month FU

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

Outcome measures

Outcome measures
Measure	Radiofrequency n=51 Participants 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. TriActive+ RF: 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.
Changes to the Surface by Visual and Photographic Analysis.	41 participants

SECONDARY outcome

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

At each of the specified time points, subjects will complete a Subject Evaluation Form assessing their opinion of improvement and overall satisfaction with treatment.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

At every treatment and follow-up visit the treated areas will be examined to evaluate side effects and adverse reactions remaining from the previous treatment session or occurring since then.

Outcome measures

Outcome data not reported

Adverse Events

Radiofrequency

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

ALESSANDRO BIZZARRI STUDY DIRECTOR

ELECTRONIC ENGINEERING EL.EN. SPA

Phone: +390558826807

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place