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This is a prospective, single centre, evaluator-blind study of the performance of fractional radiofrequency (RF) for the treatment and revision of stretch marks. The study will evaluate the progress of 15 subjects requesting treatment of stretch marks. The study will involve four treatments on both sides of the face with 4 week intervals between each treatment. Subjects will be followed at 12 and 16 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 |
|---|---|---|---|
| Venus Viva | Experimental | 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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| 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, stretch marks, rhytids and scars. Beginning with the Baseline visit (Visit 1), subjects will receive a total of 4 treatments approximately 4 weeks apart. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Volume of Striae Via Antera 3D Imaging System Analysis From Baseline to 16 Weeks Post-final Treatment | Change from baseline to the follow-up visit 16 weeks post-final treatment as a percentage of baseline volume. | 16 Weeks Post-Final Treatment (Week 28) |
| Overall Stretch Mark Improvement From Baseline to 16 Weeks Post-Final Treatment Assessed by the Global Aesthetic Improvement Scale (GAIS) | 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). | 16 Weeks Post-Final Treatment (Week 28) |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Satisfaction | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skinpulse Dermatologie | Geneva | Switzerland |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| 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 | Percent Change in Volume of Striae Via Antera 3D Imaging System Analysis From Baseline to 16 Weeks Post-final Treatment | Change from baseline to the follow-up visit 16 weeks post-final treatment as a percentage of baseline volume. | Posted | Mean | Standard Error | percentage change from baseline | 16 Weeks Post-Final Treatment (Week 28) | striae sites on the body | striae sites on the body |
|
28 weeks
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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 | 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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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperpigmentation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Affairs | Venus Concept | 888-907-0115 | mgronski@venusconcept.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 9, 2019 | Jul 24, 2023 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D057896 | Striae Distensae |
| ID | Term |
|---|---|
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| 16 Weeks Post-Final Treatment (Week 28) |
| Subject Scale - Visual Analog Scale for Pain | 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. | Treatment 1 (Week 1), Treatment 2 (Week 4), Treatment 3 (Week 8), Treatment 4 (Week 12) |
| Subject Scale - 5 Point Scale for Treatment Tolerability | 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. | Treatment 1 (Week 1), Treatment 2 (Week 4), Treatment 3 (Week 8), Treatment 4 (Week 12) |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Fitzpatrick Skin Type | The Fitzpatrick skin type (or phototype) describes a way to classify the skin by its reaction to exposure to sunlight. It is based on the amount of melanin in in the skin. Darker skin is a higher category. The PI evaluated the subjects' skin and categorized into a Fitzpatrick skin type. A person's Fitzpatrick score is set and does not change. | Count of Participants | Participants |
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| Units | Counts |
|---|
| Participants |
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| striae sites on the body |
|
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| Primary | Overall Stretch Mark Improvement From Baseline to 16 Weeks Post-Final Treatment Assessed by the Global Aesthetic Improvement Scale (GAIS) | 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). | Posted | Mean | Standard Error | units on a scale | 16 Weeks Post-Final Treatment (Week 28) |
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| Secondary | Subject Satisfaction | 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. | Posted | Mean | Standard Error | units on a scale | 16 Weeks Post-Final Treatment (Week 28) |
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| Secondary | Subject Scale - Visual Analog Scale for Pain | 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. | Posted | Mean | Standard Error | units on a scale | Treatment 1 (Week 1), Treatment 2 (Week 4), Treatment 3 (Week 8), Treatment 4 (Week 12) |
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| Secondary | Subject Scale - 5 Point Scale for Treatment Tolerability | 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. | Posted | Mean | Standard Error | units on a scale | Treatment 1 (Week 1), Treatment 2 (Week 4), Treatment 3 (Week 8), Treatment 4 (Week 12) |
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