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Prospective, single centre, evaluator-blind study of the safety and performance of fractional radiofrequency (RF) for the treatment and reduction of acne scarring. The study will evaluate the progress of 15 subjects requesting treatment of acne scarring. The study will involve three treatments on both sides of the face with 3-5 week intervals between each treatment. Subjects will be followed at 6 and 12 weeks after their last treatment. Analysis will be performed on all subjects who receive at least one treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Other | Device: Venus Viva |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venus Viva | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Acne Scar Improvement | 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). | 12 weeks post-final treatment (approximately Week 20) |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Satisfaction | 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. | 12 weeks post-final treatment (approximately Week 20) |
| Subject Scale - Visual Analog Scale for Pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Gronski | Venus Concept | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sadick Research Group | New York | New York | 10075 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6 Weeks After Treatment |
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| 12 Weeks After Treatment |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Acne Scar Improvement | 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). | Posted | Mean | Standard Error | units on a scale | 12 weeks post-final treatment (approximately Week 20) | Sides of face | Sides of face |
|
5 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 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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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperpigmentation | Skin and subcutaneous tissue disorders | Systematic Assessment | Mild, Probably related |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Affairs | Venus Concept | 888-907-0115 | mgronski@venusconcept.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 9, 2018 | Jun 21, 2023 | Prot_SAP_000.pdf |
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Blinded evaluation of photographs taken at baseline and at 6, 12 weeks post final treatment by independent evaluators.
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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. |
| Immediately post-treatment at each treatment (average of all 3 treatments) |
| Treatment Tolerability | Subjects' assessment of treatment tolerability as measured by a 5-point scale ranging from 0 (Very Intolerable) to 4 (Very Tolerable). | Immediately post-treatment at each treatment (mean of the tolerability scores following each of the 3 treatments) |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
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| Secondary | Subject Satisfaction | 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. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks post-final treatment (approximately Week 20) |
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| Secondary | Subject Scale - Visual Analog Scale for Pain | 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. | Posted | Mean | Standard Deviation | units on a scale | Immediately post-treatment at each treatment (average of all 3 treatments) |
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| Secondary | Treatment Tolerability | Subjects' assessment of treatment tolerability as measured by a 5-point scale ranging from 0 (Very Intolerable) to 4 (Very Tolerable). | Posted | Mean | Standard Deviation | units on a scale | Immediately post-treatment at each treatment (mean of the tolerability scores following each of the 3 treatments) |
|
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| 0 |
| 14 |
| 0 |
| 14 |
| 3 |
| 14 |
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| Head Cold | Infections and infestations | Systematic Assessment | Mild, Not-related to treatment |
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| Shingles | Infections and infestations | Systematic Assessment | Moderate, Not related to treatment |
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