Trial Outcomes & Findings for Clinical Evaluation of Fractional Radiofrequency for the Treatment of Acne Scarring (NCT NCT03767153)
NCT ID: NCT03767153
Last Updated: 2021-03-23
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
12 Weeks Post-Final Treatment
Results posted on
2021-03-23
Participant Flow
Participant milestones
| Measure |
80 Pin Applicator
Venus Viva: The Venus Viva™ fractional RF applicator has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.
Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. The left and right side of the face will be treated and assessed as independent sites, and the same applicator tip configuration will be used to treat both sides at all 3 treatment visits.
|
160 Pin Applicator
Venus Viva: The Venus Viva™ fractional RF applicator has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.
Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. The left and right side of the face will be treated and assessed as independent sites, and the same applicator tip configuration will be used to treat both sides at all 3 treatment visits.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
11
|
|
Overall Study
COMPLETED
|
14
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Evaluation of Fractional Radiofrequency for the Treatment of Acne Scarring
Baseline characteristics by cohort
| Measure |
80 Pin Applicator
n=14 Participants
Venus Viva: The Venus Viva™ fractional RF applicator has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.
Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. The left and right side of the face will be treated and assessed as independent sites, and the same applicator tip configuration will be used to treat both sides at all 3 treatment visits.
|
160 Pin Applicator
n=11 Participants
Venus Viva: The Venus Viva™ fractional RF applicator has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.
Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. The left and right side of the face will be treated and assessed as independent sites, and the same applicator tip configuration will be used to treat both sides at all 3 treatment visits.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.2 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
45.0 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
45.7 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
11 participants
n=7 Participants
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 Weeks Post-Final TreatmentEvaluate 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
| Measure |
80 Pin Applicator
n=14 Participants
Venus Viva: The Venus Viva™ fractional RF applicator has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.
Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. The left and right side of the face will be treated and assessed as independent sites, and the same applicator tip configuration will be used to treat both sides at all 3 treatment visits.
|
160 Pin Applicator
n=11 Participants
Venus Viva: The Venus Viva™ fractional RF applicator has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.
Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. The left and right side of the face will be treated and assessed as independent sites, and the same applicator tip configuration will be used to treat both sides at all 3 treatment visits.
|
|---|---|---|
|
Overall Acne Scar Improvement Assessed by the Global Aesthetic Improvement Scale (GAIS) at 12 Weeks.
|
1.06 score on a scale
Standard Error 0.13
|
0.85 score on a scale
Standard Error 0.13
|
SECONDARY outcome
Timeframe: 6 Weeks and 12 Weeks Post- Final TreatmentSubjects' 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
| Measure |
80 Pin Applicator
n=14 Participants
Venus Viva: The Venus Viva™ fractional RF applicator has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.
Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. The left and right side of the face will be treated and assessed as independent sites, and the same applicator tip configuration will be used to treat both sides at all 3 treatment visits.
|
160 Pin Applicator
n=11 Participants
Venus Viva: The Venus Viva™ fractional RF applicator has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.
Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. The left and right side of the face will be treated and assessed as independent sites, and the same applicator tip configuration will be used to treat both sides at all 3 treatment visits.
|
|---|---|---|
|
Subject Satisfaction
6-weeks
|
3.25 score on a scale
Standard Error 0.18
|
3.55 score on a scale
Standard Error 0.21
|
|
Subject Satisfaction
12-weeks
|
3.18 score on a scale
Standard Error 0.18
|
3.36 score on a scale
Standard Error 0.24
|
SECONDARY outcome
Timeframe: 12 Weeks Post-Final TreatmentSubject's assessment of discomfort and pain after treatments as measured by a 10 cm visual analog scale (VAS). The Visual Analog Scale is a scale from 0 cm (no pain) and 10 cm (pain as bad as it can be). Possible responses were of 0 to 0.4 cm can be considered (no pain); 0.5 to 4.4 cm (mild pain), 4.5 to 7.4 cm (moderate pain), and 7.5 to 10 cm (severe pain).
Outcome measures
| Measure |
80 Pin Applicator
n=14 Participants
Venus Viva: The Venus Viva™ fractional RF applicator has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.
Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. The left and right side of the face will be treated and assessed as independent sites, and the same applicator tip configuration will be used to treat both sides at all 3 treatment visits.
|
160 Pin Applicator
n=11 Participants
Venus Viva: The Venus Viva™ fractional RF applicator has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.
Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. The left and right side of the face will be treated and assessed as independent sites, and the same applicator tip configuration will be used to treat both sides at all 3 treatment visits.
|
|---|---|---|
|
Subject Scale - Visual Analog Scale for Pain
|
2.23 cm
Standard Error 0.26
|
2.05 cm
Standard Error 0.27
|
SECONDARY outcome
Timeframe: Up to 12 Weeks Post-Final TreatmentSubjects experiencing a treatment-related adverse event (AE) by 12 weeks post-treatment.
Outcome measures
| Measure |
80 Pin Applicator
n=14 Participants
Venus Viva: The Venus Viva™ fractional RF applicator has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.
Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. The left and right side of the face will be treated and assessed as independent sites, and the same applicator tip configuration will be used to treat both sides at all 3 treatment visits.
|
160 Pin Applicator
n=11 Participants
Venus Viva: The Venus Viva™ fractional RF applicator has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.
Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. The left and right side of the face will be treated and assessed as independent sites, and the same applicator tip configuration will be used to treat both sides at all 3 treatment visits.
|
|---|---|---|
|
Number of Participants With Treatment-Related Adverse Events [Safety]
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 Weeks Post-Final TreatmentSubject'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
| Measure |
80 Pin Applicator
n=14 Participants
Venus Viva: The Venus Viva™ fractional RF applicator has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.
Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. The left and right side of the face will be treated and assessed as independent sites, and the same applicator tip configuration will be used to treat both sides at all 3 treatment visits.
|
160 Pin Applicator
n=11 Participants
Venus Viva: The Venus Viva™ fractional RF applicator has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.
Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. The left and right side of the face will be treated and assessed as independent sites, and the same applicator tip configuration will be used to treat both sides at all 3 treatment visits.
|
|---|---|---|
|
Subject Scale - 5 Point Scale for Treatment Tolerability
|
3.36 score on a scale
Standard Error 0.07
|
3.48 score on a scale
Standard Error 0.06
|
Adverse Events
80 Pin Applicator
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
160 Pin Applicator
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place