Trial Outcomes & Findings for Radiofrequency and Pulsed Electromagnetic Field Treatment of Skin Laxity of the Mon Pubis, Labia and Vaginal Introitus (NCT NCT02770287)
NCT ID: NCT02770287
Last Updated: 2020-04-17
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
Baseline - Day 1, Follow-up visit - Day 85
Results posted on
2020-04-17
Participant Flow
Single center, baseline-controlled, open-label study. First subject enrolled March 26, 2016 and last subject completed the study on June 28, 2016.
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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11
|
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Overall Study
COMPLETED
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11
|
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Radiofrequency and Pulsed Electromagnetic Field Treatment of Skin Laxity of the Mon Pubis, Labia and Vaginal Introitus
Baseline characteristics by cohort
| Measure |
Venus Freeze Diamond Polar
n=11 Participants
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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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
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Age, Categorical
Between 18 and 65 years
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11 Participants
n=93 Participants
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Age, Categorical
>=65 years
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0 Participants
n=93 Participants
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Sex: Female, Male
Female
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11 Participants
n=93 Participants
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Sex: Female, Male
Male
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0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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2 Participants
n=93 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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9 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Asian
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1 Participants
n=93 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
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1 Participants
n=93 Participants
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Race (NIH/OMB)
White
|
9 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
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Region of Enrollment
United States
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11 Participants
n=93 Participants
|
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Baseline photograph of treatment area
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11 participants
n=93 Participants
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PRIMARY outcome
Timeframe: Baseline - Day 1, Follow-up visit - Day 85Improvement 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.
Outcome measures
| Measure |
Venus Freeze Diamond Polar
n=8 Participants
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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|---|---|
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General Skin Appearance of Mons Pubis and Labia
GAIS Very Much Improved
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3 Participants
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General Skin Appearance of Mons Pubis and Labia
GAIS Much Improved
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4 Participants
|
|
General Skin Appearance of Mons Pubis and Labia
GAIS Improved
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1 Participants
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SECONDARY outcome
Timeframe: Treatment 1 - Day 1, Treatment 2 - Day 29, Treatment 3 - Day 57Population: Subjects reported 26 VAS scores for treatment 1, treatment 2 and treatment 3 of the labia
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).
Outcome measures
| Measure |
Venus Freeze Diamond Polar
n=26 Participants
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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|---|---|
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Visual Analogue Scale (VAS)
Treatment 1
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1.6 score on a scale
Interval 0.1 to 7.3
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Visual Analogue Scale (VAS)
Treatment 2
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1.7 score on a scale
Interval 0.2 to 7.9
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Visual Analogue Scale (VAS)
Treatment 3
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1.9 score on a scale
Interval 0.1 to 6.6
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SECONDARY outcome
Timeframe: Treatment 1 - Day 1, Treatment 2 - Day 29, Treatment 3 - Day 57Population: Subjects reported 26 VAS scores for treatment 1, treatment 2 and treatment 3 of the mons pubis
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).
Outcome measures
| Measure |
Venus Freeze Diamond Polar
n=26 Participants
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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|---|---|
|
Visual Analog Scale (VAS)
Treatment 1
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1.2 score on a scale
Interval 0.1 to 3.8
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Visual Analog Scale (VAS)
Treatment 2
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0.9 score on a scale
Interval 0.1 to 2.8
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Visual Analog Scale (VAS)
Treatment 3
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1.2 score on a scale
Interval 0.1 to 3.5
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SECONDARY outcome
Timeframe: Treatment 1 - Day 1, Treatment 2 - Day 29, Treatment 3 - Day 57, Follow-up visit - Day 85Population: 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.
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.
Outcome measures
| Measure |
Venus Freeze Diamond Polar
n=11 Participants
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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|---|---|
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Vaginal pH
Treatment 1
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4.5 score on a scale
Interval 3.9 to 4.8
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Vaginal pH
Treatment 2
|
4.3 score on a scale
Interval 3.9 to 4.5
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Vaginal pH
Treatment 3
|
4.4 score on a scale
Interval 4.2 to 4.5
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Vaginal pH
Follow up Visit
|
4.3 score on a scale
Interval 4.1 to 4.5
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Adverse Events
Venus Freeze Diamond Polar
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Venus Freeze Diamond Polar
n=11 participants at risk
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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|---|---|
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Reproductive system and breast disorders
Vaginal canal pain
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9.1%
1/11 • Number of events 1 • Adverse event data was collected for 3 months and 2 days.
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Skin and subcutaneous tissue disorders
Pain, biopsy site
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18.2%
2/11 • Number of events 2 • Adverse event data was collected for 3 months and 2 days.
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Reproductive system and breast disorders
Achy cramps, contractions
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9.1%
1/11 • Number of events 1 • Adverse event data was collected for 3 months and 2 days.
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Reproductive system and breast disorders
Blistering inside vaginal canal
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9.1%
1/11 • Number of events 1 • Adverse event data was collected for 3 months and 2 days.
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Reproductive system and breast disorders
Feeling of 'blistering' inside vaginal canal
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9.1%
1/11 • Number of events 1 • Adverse event data was collected for 3 months and 2 days.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place