Trial Outcomes & Findings for Fractional Radiofrequency for the Treatment and Reduction of Acne Scars and Wrinkles (NCT NCT04057768)

Results Overview

Evaluate the efficacy of overall facial wrinkles improvement assessed live by the Investigator and a subject assessment of facial appearance including the Fitzpatrick Wrinkle and Elastosis Scale (FWES). The FWES is a 9 point scale. Three independent evaluators evaluated before and after photographs and graded them for change. Possible responses were: a score of 1 - 3 (Mild) indicates fine texture changes with subtly accentuated skin lines, a score of 4 - 6 (Moderate) indicates distinct papular elastosis (\[indvidual papules with yellow translucency under direct lighting\] and dyschromia and a score of 7 - 9 (Severe) indicates multipapular and confluent elastosis \[thickened yellow and pallid\] approaching or consistent with cutis rhomboidalis. A lower class and a lower score means a better outcome.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

12 Weeks Post-Final Treatment

Results posted on

2021-06-29

Participant Flow

Participant milestones

Participant milestones
Measure	Venus Viva™ Device Venus Viva™ Device: The Venus Viva™ fractional RF device has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fractional Radiofrequency for the Treatment and Reduction of Acne Scars and Wrinkles

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=10 Participants Device: Venus Viva Venus Viva: The Venus Viva™ fractional RF device has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.
Age, Continuous	62.7 years STANDARD_DEVIATION 8.4 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 Weeks Post-Final Treatment

Evaluate the efficacy of overall facial wrinkles improvement assessed live by the Investigator and a subject assessment of facial appearance including the Fitzpatrick Wrinkle and Elastosis Scale (FWES). The FWES is a 9 point scale. Three independent evaluators evaluated before and after photographs and graded them for change. Possible responses were: a score of 1 - 3 (Mild) indicates fine texture changes with subtly accentuated skin lines, a score of 4 - 6 (Moderate) indicates distinct papular elastosis (\[indvidual papules with yellow translucency under direct lighting\] and dyschromia and a score of 7 - 9 (Severe) indicates multipapular and confluent elastosis \[thickened yellow and pallid\] approaching or consistent with cutis rhomboidalis. A lower class and a lower score means a better outcome.

Outcome measures

Outcome measures
Measure	Intervention n=10 Participants Device: Venus Viva Venus Viva: The Venus Viva™ fractional RF device has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.
Overall Wrinkle Improvement Assessed by the Fitzpatrick Wrinkle and Elastosis Scale (FWES) at 12 Weeks Post-Final Treatment Baseline	5.97 units on a scale Standard Deviation 0.20
Overall Wrinkle Improvement Assessed by the Fitzpatrick Wrinkle and Elastosis Scale (FWES) at 12 Weeks Post-Final Treatment 12-weeks	5.78 units on a scale Standard Deviation 0.22

PRIMARY outcome

Timeframe: 12 Weeks Post-Final Treatment

Evaluate the efficacy of overall facial acne scar improvement assessed live by the Investigator and a subject assessment of facial appearance including the Global Aesthetic Improvement Scale (GAIS). The Global Aesthetic Improvement Scale is a seven-grade subjective test. Three independent evaluators evaluated before and after photographs and graded them for change. Possible responses were (3) Very Much Improved, (2) Much Improved, (1) Improved, (0) No Change, (-1) Worse, (-2) Much Worse, and (-3) Very Much Worse. For reporting of outcomes, the higher the GAIS value, the greater the improvement (Range -3 to 3).

Outcome measures

Outcome measures
Measure	Intervention n=10 Participants Device: Venus Viva Venus Viva: The Venus Viva™ fractional RF device has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.
Overall Acne Scar Improvement Assessed by the Global Aesthetic Improvement Scale (GAIS) at 12 Weeks Post-Final Treatment	0.4 units on a scale Standard Error 0.1

SECONDARY outcome

Timeframe: 6 and 12 Weeks Post- Final Treatment

Subjects' assessment of satisfaction with the treatment using a 5 point Subject Satisfaction Scale at 6 Weeks and 12 weeks post-treatment. The Subject Satisfaction Scale is a five-grade subjective test. Participant were asked their satisfaction level post treatment. Possible responses were (4) Very Satisfied, (3) Satisfied, (2) Having No Opinion, (1) Unsatisfied, and (0) Very Unsatisfied.

Outcome measures

Outcome measures
Measure	Intervention n=10 Participants Device: Venus Viva Venus Viva: The Venus Viva™ fractional RF device has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.
Subject Satisfaction 6-weeks	3.22 units on a scale Standard Error 0.22
Subject Satisfaction 12-weeks	3.20 units on a scale Standard Error 0.25

SECONDARY outcome

Timeframe: 12 Weeks Post-Final Treatment

Subject's assessment of discomfort and pain after treatments as measured by a 10 point Wong-Baker FACES Pain Scale The Wong-Baker FACES pain scoring system is a subject-reported instrument using a scale of 0 (no pain) to 10 (most pain). Possible responses, 9 to 10 shows Hurts Worst, 7 to 8 shows Hurts Whole Lot, 5 to 6 shows Hurts Even More, 3 to 4 shows Hurts Little More, 1 to 2 shows Hurts Little Bit, 0 shows No Hurt.

Outcome measures

Outcome measures
Measure	Intervention n=10 Participants Device: Venus Viva Venus Viva: The Venus Viva™ fractional RF device has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.
Subject Scale - Wong Baker FACES Pain Scale	3.93 units on a scale Standard Error 0.39

SECONDARY outcome

Timeframe: 8 Weeks Post-Final Treatment

Subject's assessment of treatment tolerability as measured by a 5 point scale. Participant were asked their tolerability level post treatment. Possible scores were; (4) Very Tolerable, (3) Tolerable, (2) Having No Opinion, (1) Intolerable, and (0) Very Intolerable.

Outcome measures

Outcome measures
Measure	Intervention n=10 Participants Device: Venus Viva Venus Viva: The Venus Viva™ fractional RF device has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.
Subject Scale - 5 Point Scale for Treatment Tolerability	3.10 units on a scale Standard Error 0.10

SECONDARY outcome

Timeframe: Up to 12 Weeks Post-Treatment

Subjects experiencing a treatment-related adverse event (AE) by 12 weeks post-treatment. A treatment-related adverse event was any untoward medical occurrence attributed to the device in a participant who received treatment. Relatedness to the device was assessed by the investigator.

Outcome measures

Outcome measures
Measure	Intervention n=10 Participants Device: Venus Viva Venus Viva: The Venus Viva™ fractional RF device has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.
Number of Participants With Treatment-Related Adverse Events	0 Participants

Adverse Events

Intervention

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

Clinical Research Manager

Venus Concept

Phone: 888-907-0115

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place