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The study will confirm that the Freeze Diamond polar applicator is safe for treating the Mons pubis and Labia, and will result in improvement in general skin appearance including an improvement in skin irregularities and skin laxity.
This is a single-center, open-label, prospective study. Ten (10) subjects that meet the inclusion criteria will be enrolled from the site's pool of patients. Subjects should be a female at the age of 25-65, and have a suitable treatment area (e.g. skin irregularities and/or unwanted skin laxity in the Mons pubis, Introitus and/or Labia area).
Subjects will receive three treatments with the study device, at four week intervals, followed by one month follow-up visits after the last treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venus Freeze Diamond Polar treatment | Experimental | Subjects will receive three treatments with the study device, at four week intervals, followed by a one month follow-up visit after the last treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venus Freeze Diamond Polar | Device | The Venus Freeze Diamond Polar is a non-invasive dermatological treatment system that combines Multi Polar Radiofrequency and Pulsed Magnetic Fields. The radiofrequency energy penetrates the skin and results in tissue heating that has known effect on skin laxity, the magnetic field that is simultaneously induces increases fibroblast collagen production through non thermal mechanism and contributes to the clinical effect of skin laxity improvement. Only the Diamond Polar applicator will be used in this study for the treatment of the Mons pubis, vaginal introitus and Labia. Minor modification to the hand-piece for operator and/or patient comfort may occur mid-study, however no change in range of energy modality or amount of energy delivered will occur at any point during the study. |
| Measure | Description | Time Frame |
|---|---|---|
| General Skin Appearance of Mons Pubis and Labia | Improvement in general skin appearance at follow-up visit 3 as compared to baseline as assessed by independent blinded evaluator by photographic assessment, utilizing the Global Aesthetic Improvement Scale (GAIS) where 3 = very much improved, 2 = much improved, 1 = improved, 0 = no change, -1 = worse, -2 = much worse and -3 = very much worse where higher scores indicate a better outcome. | Baseline - Day 1, Follow-up visit - Day 85 |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale (VAS) | The subject records their measure of discomfort and pain associated with all treatments of the labia as a vertical line drawn on a 100 mm horizontal line on which the discomfort and pain intensity is represented by a point between the extremes of "no pain at all" (a value of 0 mm) and "worst pain imaginable (a value of 100 mm). | Treatment 1 - Day 1, Treatment 2 - Day 29, Treatment 3 - Day 57 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Reiz | Venus Concept | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Revive Wellness Center | Torrance | California | 90505 | United States |
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Single center, baseline-controlled, open-label study. First subject enrolled March 26, 2016 and last subject completed the study on June 28, 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group | Subjects will receive three treatments with the study device, at four week intervals, followed by a one month follow-up visit after the last treatment. Venus Freeze Diamond Polar: The Venus Freeze Diamond Polar is a non-invasive dermatological treatment system combines Multi Polar Radiofrequency and Pulsed Magnetic Fields. The radiofrequency energy penetrates the skin and results in tissue heating that has known effect on skin laxity, the magnetic field that is simultaneously induces increases fibroblast collagen production through non thermal mechanism and contributes to the clinical effect of skin laxity improvement. Only the Diamond Polar applicator will be used in this study for the treatment of the Mons pubis, vaginal introitus and Labia. Minor modification to the hand-piece for operator and/or patient comfort may occur mid-study, however no change in range of energy modality or amount of energy delivered will occur at any point during the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Venus Freeze Diamond Polar | Subjects will receive three treatments with the study device, at four week intervals, followed by a one month follow-up visit after the last treatment. Venus Freeze Diamond Polar: The Venus Freeze Diamond Polar is a non-invasive dermatological treatment system combines Multi Polar Radiofrequency and Pulsed Magnetic Fields. The radiofrequency energy penetrates the skin and results in tissue heating that has known effect on skin laxity, the magnetic field that is simultaneously induces increases fibroblast collagen production through non thermal mechanism and contributes to the clinical effect of skin laxity improvement. Only the Diamond Polar applicator will be used in this study for the treatment of the Mons pubis, vaginal introitus and Labia. Minor modification to the hand-piece for operator and/or patient comfort may occur mid-study, however no change in range of energy modality or amount of energy delivered will occur at any point during the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | General Skin Appearance of Mons Pubis and Labia | Improvement in general skin appearance at follow-up visit 3 as compared to baseline as assessed by independent blinded evaluator by photographic assessment, utilizing the Global Aesthetic Improvement Scale (GAIS) where 3 = very much improved, 2 = much improved, 1 = improved, 0 = no change, -1 = worse, -2 = much worse and -3 = very much worse where higher scores indicate a better outcome. | Posted | Count of Participants | Participants | Baseline - Day 1, Follow-up visit - Day 85 |
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Adverse event data was collected for 3 months and 2 days.
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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 Freeze Diamond Polar | Subjects will receive three treatments with the study device, at four week intervals, followed by a one month follow-up visit after the last treatment. Venus Freeze Diamond Polar: The Venus Freeze Diamond Polar is a non-invasive dermatological treatment system combines Multi Polar Radiofrequency and Pulsed Magnetic Fields. The radiofrequency energy penetrates the skin and results in tissue heating that has known effect on skin laxity, the magnetic field that is simultaneously induces increases fibroblast collagen production through non thermal mechanism and contributes to the clinical effect of skin laxity improvement. Only the Diamond Polar applicator will be used in this study for the treatment of the Mons pubis, vaginal introitus and Labia. Minor modification to the hand-piece for operator and/or patient comfort may occur mid-study, however no change in range of energy modality or amount of energy delivered will occur at any point during the study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vaginal canal pain | Reproductive system and breast disorders | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yoni Iger | Venus Concept Ltd | 888-907-0115 | yoni@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 | Nov 25, 2016 | Apr 6, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003483 | Cutis Laxa |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
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Independent reviewer to identify the four-month photograph of the mons pubis and labia as compared to the baseline (untreated photo).
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| Visual Analog Scale (VAS) | The subject records their measure of discomfort and pain associated with all treatments of the mons pubis as a vertical line drawn on a 100 mm horizontal line on which the discomfort and pain intensity is represented by a point between the extremes of "no pain at all" (a value of 0 mm) and "worst pain imaginable (a value of 100 mm). | Treatment 1 - Day 1, Treatment 2 - Day 29, Treatment 3 - Day 57 |
| Vaginal pH | Vaginal pH was obtained at each study visit. The pH is a numeric value from 0 to 14 expressing the acidity or alkalinity of the vaginal fluids where 7 is neutral, lower values are more acidic (value of 0) and higher values more alkaline (value of 14). A healthly vaginal pH has a value of 3.8 to 4.5. | Treatment 1 - Day 1, Treatment 2 - Day 29, Treatment 3 - Day 57, Follow-up visit - Day 85 |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | No |
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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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| Region of Enrollment | Count of Participants | Participants |
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| Baseline photograph of treatment area | Number | participants |
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| Secondary | Visual Analogue Scale (VAS) | The subject records their measure of discomfort and pain associated with all treatments of the labia as a vertical line drawn on a 100 mm horizontal line on which the discomfort and pain intensity is represented by a point between the extremes of "no pain at all" (a value of 0 mm) and "worst pain imaginable (a value of 100 mm). | Subjects reported 26 VAS scores for treatment 1, treatment 2 and treatment 3 of the labia | Posted | Mean | Full Range | score on a scale | Treatment 1 - Day 1, Treatment 2 - Day 29, Treatment 3 - Day 57 |
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| Secondary | Visual Analog Scale (VAS) | The subject records their measure of discomfort and pain associated with all treatments of the mons pubis as a vertical line drawn on a 100 mm horizontal line on which the discomfort and pain intensity is represented by a point between the extremes of "no pain at all" (a value of 0 mm) and "worst pain imaginable (a value of 100 mm). | Subjects reported 26 VAS scores for treatment 1, treatment 2 and treatment 3 of the mons pubis | Posted | Mean | Full Range | score on a scale | Treatment 1 - Day 1, Treatment 2 - Day 29, Treatment 3 - Day 57 |
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| Secondary | Vaginal pH | Vaginal pH was obtained at each study visit. The pH is a numeric value from 0 to 14 expressing the acidity or alkalinity of the vaginal fluids where 7 is neutral, lower values are more acidic (value of 0) and higher values more alkaline (value of 14). A healthly vaginal pH has a value of 3.8 to 4.5. | Vaginal pH was obtained for 11 subjects at the treatment 1 visit, 9 subjects for the treatment 2 visit, 8 subjects for the treatment 3 visit and only 5 subjects at the follow up visit. No baseline vaginal pH's were obtained. | Posted | Mean | Full Range | score on a scale | Treatment 1 - Day 1, Treatment 2 - Day 29, Treatment 3 - Day 57, Follow-up visit - Day 85 |
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|
| 0 |
| 11 |
| 0 |
| 11 |
| 6 |
| 11 |
| Pain, biopsy site | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| Achy cramps, contractions | Reproductive system and breast disorders | MedDRA (10.0) | Systematic Assessment |
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| Blistering inside vaginal canal | Reproductive system and breast disorders | MedDRA (10.0) | Systematic Assessment |
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| Feeling of 'blistering' inside vaginal canal | Reproductive system and breast disorders | MedDRA (10.0) | Systematic Assessment |
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| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Treatment 3 |
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| Follow up Visit |
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