Trial Outcomes & Findings for Clinical Evaluation of Fractional Radiofrequency for the Treatment and Reduction of Facial Wrinkles (NCT NCT03831477)
NCT ID: NCT03831477
Last Updated: 2023-09-06
Results Overview
Change in facial wrinkles at 12 weeks post-treatment compared to baseline as assessed by blinded evaluators by photographic assessment utilizing the 9-point Fitzpatrick Wrinkle and Elastosis Scale (FWES). Scores of 1-3 indicate fine wrinkles with mild elastosis, scores 4-6 fine to moderate depth wrinkles with moderate elastosis and 7-9 fine to deep wrinkles with severe elastosis.
COMPLETED
NA
15 participants
12 Weeks Post Final Treatment
2023-09-06
Participant Flow
Participant milestones
| Measure |
Viva Treatment
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. Subjects received 3 treatments on both sides of the face with 3-5 week intervals between each treatment
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|---|---|
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Overall Study
STARTED
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15
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Overall Study
COMPLETED
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13
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Evaluation of Fractional Radiofrequency for the Treatment and Reduction of Facial Wrinkles
Baseline characteristics by cohort
| Measure |
Viva Treatment
n=15 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. Subjects received 3 treatments on both sides of the face with 3-5 week intervals between each treatment
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|---|---|
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Age, Continuous
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56.7 years
STANDARD_DEVIATION 10.2 • n=99 Participants
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Sex: Female, Male
Female
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15 Participants
n=99 Participants
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Sex: Female, Male
Male
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0 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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5 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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10 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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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
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Race (NIH/OMB)
Asian
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=99 Participants
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Race (NIH/OMB)
White
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15 Participants
n=99 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=99 Participants
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PRIMARY outcome
Timeframe: 12 Weeks Post Final TreatmentChange in facial wrinkles at 12 weeks post-treatment compared to baseline as assessed by blinded evaluators by photographic assessment utilizing the 9-point Fitzpatrick Wrinkle and Elastosis Scale (FWES). Scores of 1-3 indicate fine wrinkles with mild elastosis, scores 4-6 fine to moderate depth wrinkles with moderate elastosis and 7-9 fine to deep wrinkles with severe elastosis.
Outcome measures
| Measure |
Viva Treatment
n=20 Sides of the face
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. Subjects received 3 treatments on both sides of the face with 3-5 week intervals between each treatment
|
|---|---|
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Change in Facial Wrinkles at 12 Weeks Post Final Treatment Compared to Baseline
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-0.10 units on a scale
Standard Error 0.12
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SECONDARY outcome
Timeframe: 12 Weeks Post-Final TreatmentSubjects' assessment of satisfaction with the treatment using a 5-point Subject Satisfaction Scale at 12 weeks post-treatment with 0 being "very unsatisfied" and 4 "very satisfied".
Outcome measures
| Measure |
Viva Treatment
n=12 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. Subjects received 3 treatments on both sides of the face with 3-5 week intervals between each treatment
|
|---|---|
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Subject Satisfaction
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2.5 units on a scale
Standard Deviation 1.3
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SECONDARY outcome
Timeframe: An average of all 3 treatmentsSubject'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 maximal pain. VAS was measured following each of the 3 treatments.
Outcome measures
| Measure |
Viva Treatment
n=15 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. Subjects received 3 treatments on both sides of the face with 3-5 week intervals between each treatment
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|---|---|
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Subject Scale - Visual Analog Scale for Pain
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3.2 units on a scale
Standard Deviation 2.2
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SECONDARY outcome
Timeframe: An average of all 3 treatmentsSubject's assessment of treatment tolerability as measured by a 5-point scale with 4 being "very tolerable" and 0 "very intolerable". VAS was measured following each of the 3 treatments.
Outcome measures
| Measure |
Viva Treatment
n=15 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. Subjects received 3 treatments on both sides of the face with 3-5 week intervals between each treatment
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|---|---|
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Subject Scale - 5 Point Scale for Treatment Tolerability
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3.55 units on a scale
Standard Deviation 0.50
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Adverse Events
Viva Treatment
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