Trial Outcomes & Findings for Fractional Radiofrequency for the Treatment and Reduction of Facial Wrinkles (NCT NCT03776461)
NCT ID: NCT03776461
Last Updated: 2023-08-15
Results Overview
Subjects' assessment of satisfaction with the treatment using a 5 point Subject Satisfaction Scale (0=Very Unsatisfied, 4=Very Satisfied) at 6 weeks and 12 weeks post-treatment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
12 Weeks Post Last Treatment (Around Week 20)
Results posted on
2023-08-15
Participant Flow
Participant milestones
| Measure |
80-pin Applicator
3 treatments with either the Venus Viva 80-pin or 160-tip applicator at 0, 4, and 8 weeks.
Venus Viva: The Venus Viva™ is a non-invasive medical aesthetic device, intended for use in dermatologic and general surgical procedures, requiring ablation and resurfacing of the skin, using the Viva applicator.
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|---|---|
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Overall Study
STARTED
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25
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Overall Study
COMPLETED
|
18
|
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Overall Study
NOT COMPLETED
|
7
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fractional Radiofrequency for the Treatment and Reduction of Facial Wrinkles
Baseline characteristics by cohort
| Measure |
All Participants
n=25 Participants
Venus Viva: The Venus Viva™ is a non-invasive medical aesthetic device, intended for use in dermatologic and general surgical procedures, requiring ablation and resurfacing of the skin, using the Viva applicator.
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|---|---|
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Age, Continuous
|
62.4 years
STANDARD_DEVIATION 7.7 • n=99 Participants
|
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Sex: Female, Male
Female
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24 Participants
n=99 Participants
|
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Sex: Female, Male
Male
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1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=99 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=99 Participants
|
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Race (NIH/OMB)
More than one race
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0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
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Fitzpatrick Skin Type
I
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0 participants
n=99 Participants
|
|
Fitzpatrick Skin Type
II
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14 participants
n=99 Participants
|
|
Fitzpatrick Skin Type
III
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10 participants
n=99 Participants
|
|
Fitzpatrick Skin Type
IV
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0 participants
n=99 Participants
|
|
Fitzpatrick Skin Type
V
|
0 participants
n=99 Participants
|
|
Fitzpatrick Skin Type
VI
|
0 participants
n=99 Participants
|
|
Fitzpatrick Skin Type
Unknown
|
1 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 12 Weeks Post Last Treatment (Around Week 20)Subjects' assessment of satisfaction with the treatment using a 5 point Subject Satisfaction Scale (0=Very Unsatisfied, 4=Very Satisfied) at 6 weeks and 12 weeks post-treatment.
Outcome measures
| Measure |
All Subjects
n=18 Participants
3 treatments with Viva at 0, 4, and 8 weeks. Assessment at Week 20.
Venus Viva: The Venus Viva™ is a non-invasive medical aesthetic device, intended for use in dermatologic and general surgical procedures, requiring ablation and resurfacing of the skin, using the Viva applicator.
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|---|---|
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Subject Satisfaction
|
2.8 score on a scale
Standard Deviation 0.8
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PRIMARY outcome
Timeframe: 6 Weeks Post Last Treatment (Around Week 14)Subjects' assessment of satisfaction with the treatment using a 5 point Subject Satisfaction Scale (0=Very Unsatisfied, 4=Very Satisfied) at 6 weeks and 12 weeks post-treatment.
Outcome measures
| Measure |
All Subjects
n=18 Participants
3 treatments with Viva at 0, 4, and 8 weeks. Assessment at Week 20.
Venus Viva: The Venus Viva™ is a non-invasive medical aesthetic device, intended for use in dermatologic and general surgical procedures, requiring ablation and resurfacing of the skin, using the Viva applicator.
|
|---|---|
|
Subject Satisfaction
|
2.6 units on a scale
Standard Deviation 0.8
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SECONDARY outcome
Timeframe: Post Treatment at the Baseline, 4 Week and 8 Week treatment visitsSubject's 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. For each subject, the mean VAS score was taken from the 3 treatments.
Outcome measures
| Measure |
All Subjects
n=25 Participants
3 treatments with Viva at 0, 4, and 8 weeks. Assessment at Week 20.
Venus Viva: The Venus Viva™ is a non-invasive medical aesthetic device, intended for use in dermatologic and general surgical procedures, requiring ablation and resurfacing of the skin, using the Viva applicator.
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|---|---|
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Subject Scale - Visual Analog Scale for Pain
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3.8 units on a scale
Standard Deviation 2.4
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SECONDARY outcome
Timeframe: Post Treatment at the Baseline, 4 Week and 8 Week treatment visitsSubject's assessment of treatment tolerability as measured by a 5-point scale. For each subject the mean of tolerability results from the 3 treatments was taken.
Outcome measures
| Measure |
All Subjects
n=25 Participants
3 treatments with Viva at 0, 4, and 8 weeks. Assessment at Week 20.
Venus Viva: The Venus Viva™ is a non-invasive medical aesthetic device, intended for use in dermatologic and general surgical procedures, requiring ablation and resurfacing of the skin, using the Viva applicator.
|
|---|---|
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Subject Scale - 5 Point Scale for Treatment Tolerability With 0 Being Very Intolerable and 4 Very Tolerable.
|
3.1 score on a scale
Standard Error 0.8
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Adverse Events
All Participants
Serious events: 0 serious events
Other events: 2 other events
Deaths: 5 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Participants
n=25 participants at risk
Venus Viva: The Venus Viva™ is a non-invasive medical aesthetic device, intended for use in dermatologic and general surgical procedures, requiring ablation and resurfacing of the skin, using the Viva applicator.
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|---|---|
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Infections and infestations
Cold Sore
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8.0%
2/25 • Number of events 2 • 5 months
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place