Trial Outcomes & Findings for Clinical Evaluation of Fractional Radiofrequency for the Treatment Acne Scarring (NCT NCT03821324)
NCT ID: NCT03821324
Last Updated: 2023-08-04
Results Overview
Change in acne scarring at 12 weeks post-treatment compared to baseline as assessed by blinded evaluators using photographs a 7-point Global Aesthetic Improvement Scale (GAIS) (ranges from -3 Very Much Worse to +3 Very Much Improved).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
12 weeks post-final treatment (approximately Week 20)
Results posted on
2023-08-04
Participant Flow
Unit of analysis: Sides of face
Participant milestones
| Measure |
Intervention
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. 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.
|
|---|---|
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6 Weeks After Treatment
STARTED
|
14 28
|
|
6 Weeks After Treatment
COMPLETED
|
9 18
|
|
6 Weeks After Treatment
NOT COMPLETED
|
5 10
|
|
12 Weeks After Treatment
STARTED
|
9 18
|
|
12 Weeks After Treatment
COMPLETED
|
9 18
|
|
12 Weeks After Treatment
NOT COMPLETED
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Evaluation of Fractional Radiofrequency for the Treatment Acne Scarring
Baseline characteristics by cohort
| Measure |
Intervention
n=15 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. 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.
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|---|---|
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Age, Continuous
|
44.5 years
STANDARD_DEVIATION 11.3 • n=39 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 12 weeks post-final treatment (approximately Week 20)Change in acne scarring at 12 weeks post-treatment compared to baseline as assessed by blinded evaluators using photographs a 7-point Global Aesthetic Improvement Scale (GAIS) (ranges from -3 Very Much Worse to +3 Very Much Improved).
Outcome measures
| Measure |
12-weeks After Last Treatment
n=18 Sides of face
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. 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.
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|---|---|
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Acne Scar Improvement
|
0.26 units on a scale
Standard Error 0.12
|
SECONDARY outcome
Timeframe: 12 weeks post-final treatment (approximately Week 20)Subjects' assessment of satisfaction with the treatment using a 5-point Subject Satisfaction Scale (ranging from 0 Very Unsatisfied to 4 Very Satisfied) at 6 weeks and 12 weeks post-treatment.
Outcome measures
| Measure |
12-weeks After Last Treatment
n=9 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. 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
|
2.89 units on a scale
Standard Deviation 1.05
|
SECONDARY outcome
Timeframe: Immediately post-treatment at each treatment (average of all 3 treatments)Subjects' assessment of discomfort and pain after treatments as measured by a 10 cm visual analog scale (VAS) with 0 being no pain and 10 being pain as bad as it can be. Each subject was asked to rate their pain after each of the 3 treatments. The result is the mean of each subject's mean VAS score.
Outcome measures
| Measure |
12-weeks After Last Treatment
n=14 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. 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.
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|---|---|
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Subject Scale - Visual Analog Scale for Pain
|
3.09 units on a scale
Standard Deviation 1.92
|
SECONDARY outcome
Timeframe: Immediately post-treatment at each treatment (mean of the tolerability scores following each of the 3 treatments)Subjects' assessment of treatment tolerability as measured by a 5-point scale ranging from 0 (Very Intolerable) to 4 (Very Tolerable).
Outcome measures
| Measure |
12-weeks After Last Treatment
n=14 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. 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.
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|---|---|
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Treatment Tolerability
|
3.51 units on a scale
Standard Deviation 0.45
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intervention
n=14 participants at risk
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. Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. The left and right sides 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.
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|---|---|
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Skin and subcutaneous tissue disorders
Hyperpigmentation
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7.1%
1/14 • Number of events 1 • 5 months
|
|
Infections and infestations
Head Cold
|
7.1%
1/14 • Number of events 1 • 5 months
|
|
Infections and infestations
Shingles
|
7.1%
1/14 • Number of events 1 • 5 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place