Trial Outcomes & Findings for Clinical Evaluation of the Efficacy of Fractional Radiofrequency for the Treatment and Reduction of Stretch Marks (NCT NCT05097573)
NCT ID: NCT05097573
Last Updated: 2023-09-18
Results Overview
Change from baseline to the follow-up visit 16 weeks post-final treatment as a percentage of baseline volume.
COMPLETED
NA
17 participants
16 Weeks Post-Final Treatment (Week 28)
2023-09-18
Participant Flow
Participant milestones
| Measure |
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, stretch marks and scars. Beginning with the Baseline visit (Visit 1), subjects will receive a total of 4 treatments approximately 4 weeks apart.
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Overall Study
STARTED
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17
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Overall Study
COMPLETED
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15
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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 the Efficacy of Fractional Radiofrequency for the Treatment and Reduction of Stretch Marks
Baseline characteristics by cohort
| Measure |
Venus Viva
n=17 Participants
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, stretch marks and scars. Beginning with the Baseline visit (Visit 1), subjects will receive a total of 4 treatments approximately 4 weeks apart.
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Age, Continuous
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36.2 years
STANDARD_DEVIATION 9.1 • n=5 Participants
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Sex: Female, Male
Female
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14 Participants
n=5 Participants
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Sex: Female, Male
Male
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3 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
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Race (NIH/OMB)
White
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17 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Fitzpatrick Skin Type
I
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1 Participants
n=5 Participants
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Fitzpatrick Skin Type
II
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10 Participants
n=5 Participants
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Fitzpatrick Skin Type
III
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6 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: 16 Weeks Post-Final Treatment (Week 28)Change from baseline to the follow-up visit 16 weeks post-final treatment as a percentage of baseline volume.
Outcome measures
| Measure |
Venus Viva
n=55 striae sites on the body
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, stretch marks and scars. Beginning with the Baseline visit (Visit 1), subjects will receive a total of 4 treatments approximately 4 weeks apart.
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Percent Change in Volume of Striae Via Antera 3D Imaging System Analysis From Baseline to 16 Weeks Post-final Treatment
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-28.3 percentage change from baseline
Standard Error 4.7
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PRIMARY outcome
Timeframe: 16 Weeks Post-Final Treatment (Week 28)Evaluate the efficacy of overall stretch mark improvement assessed live by the Investigator and a subject assessment of stretch mark including the Global Aesthetic Improvement Scale (GAIS).The Global Aesthetic Improvement Scale is a seven-grade subjective test. The PI 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 |
Venus Viva
n=15 Participants
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, stretch marks and scars. Beginning with the Baseline visit (Visit 1), subjects will receive a total of 4 treatments approximately 4 weeks apart.
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Overall Stretch Mark Improvement From Baseline to 16 Weeks Post-Final Treatment Assessed by the Global Aesthetic Improvement Scale (GAIS)
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1.7 units on a scale
Standard Error 0.4
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SECONDARY outcome
Timeframe: 16 Weeks Post-Final Treatment (Week 28)Subjects' assessment of satisfaction with the treatment using a 5 point Subject Satisfaction Scale at 16 weeks post-treatment. The Subject Satisfaction Scale is a five-grade subjective test. Participants were asked to rate their satisfaction level with the results. Possible responses were (4) Very Satisfied, (3) Satisfied, (2) Having No Opinion, (1) Unsatisfied, and (0) Very Unsatisfied.
Outcome measures
| Measure |
Venus Viva
n=15 Participants
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, stretch marks and scars. Beginning with the Baseline visit (Visit 1), subjects will receive a total of 4 treatments approximately 4 weeks apart.
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Subject Satisfaction
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3.1 units on a scale
Standard Error 0.3
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SECONDARY outcome
Timeframe: Treatment 1 (Week 1), Treatment 2 (Week 4), Treatment 3 (Week 8), Treatment 4 (Week 12)Subject'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). No anaesthetic was used. An average of all 4 treatments was taken for each subject.
Outcome measures
| Measure |
Venus Viva
n=17 Participants
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, stretch marks and scars. Beginning with the Baseline visit (Visit 1), subjects will receive a total of 4 treatments approximately 4 weeks apart.
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Subject Scale - Visual Analog Scale for Pain
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3.8 units on a scale
Standard Error 0.2
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SECONDARY outcome
Timeframe: Treatment 1 (Week 1), Treatment 2 (Week 4), Treatment 3 (Week 8), Treatment 4 (Week 12)Subject's assessment of treatment tolerability as measured by a 5-point scale. Participants were asked about their tolerability level immediately post-treatment. Possible scores were; (4) Very Tolerable, (3) Tolerable, (2) Having No Opinion, (1) Intolerable, and (0) Very Intolerable. An average of all 4 treatments was taken for each subject.
Outcome measures
| Measure |
Venus Viva
n=17 Participants
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, stretch marks and scars. Beginning with the Baseline visit (Visit 1), subjects will receive a total of 4 treatments approximately 4 weeks apart.
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Subject Scale - 5 Point Scale for Treatment Tolerability
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3.1 units on a scale
Standard Error 0.2
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Adverse Events
Venus Viva
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Venus Viva
n=17 participants at risk
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, stretch marks and scars. Beginning with the Baseline visit (Visit 1), subjects will receive a total of 4 treatments approximately 4 weeks apart.
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Skin and subcutaneous tissue disorders
Hyperpigmentation
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11.8%
2/17 • Number of events 2 • 28 weeks
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place