Skin LaxityNCT02770287
Radiofrequency and Pulsed Electromagnetic Field Treatment of Skin Laxity of the Mon Pubis, Labia and Vaginal Introitus
A study testing Venus Freeze Diamond Polar in people with Skin Laxity, run by Venus Concept at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Laxity
- What is being tested?
- Venus Freeze Diamond Polar
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2016to 30 Nov 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy female between the ages of 25 and 65.
- Able to read, understand and voluntarily provide written Informed Consent;
- Able and willing to comply with the treatment/follow-up schedule and requirements;
- Fitzpatrick skin type I-VI.
- Sexual activity (vaginal intercourse once per month) in a monogamous relationship.
- Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment, and have a negative Urine Pregnancy test at baseline.
- Women requesting aesthetic benefit to the vaginal mons, introitus and labia.
Who cannot join
- Pregnant or intending to become pregnant during the course of study. A urine pregnancy test will be given to women of childbearing potential and performed during initial visit.
- Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
- Having a permanent implant in the treated area.
- Prior use of retinoids in treated area within 2 weeks of initial treatment or during the course of the study.
- Use of oral Isotretinoin (Accutane®) within 6 months of initial treatment or during the course of the study.
- Patient on systemic corticosteroid therapy 6 months prior to and throughout the course of the study.
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- Prior skin treatment with laser in treated area within 6 months of initial treatment or during the course of the study.
- Prior use of collagen, fat injections and /or other methods of skin augmentation (enhancement with injected or implanted material) in treated area within 4-6 weeks of initial treatment or during the course of the study. Treatment may not be performed at all over permanent dermal implants.
- Prior ablative resurfacing procedure in treated area with laser or other devices within 12 months of initial treatment or during the course of the study.
- Any other surgery in treated area within 12 months of initial treatment or during the course of the study.
- History of keloid formation or poor wound healing in a previously injured skin area.
- History of epidermal or dermal disorders (particularly if involving collagen or microvascularity).
- Open laceration or abrasion of any sort on the area to be treated.
- Active sexually transmitted disease (e.g. genital Herpes Simplex, condylomata) or vaginosis; any tissue biopsy will be deferred or delayed to a later time point until the infection is resolved.
- Chronic vulvar pain or vulvar dystrophy.
- History of immunosuppression/immune deficiency disorders (including human immunodeficiency virus infection or acquired immune deficiency syndrome) or use of immunosuppressive medications.
- Having any form of active cancer at the time of enrollment and during the course of the study.
- Significant concurrent illness, such as uncontrolled diabetes i.e. any disease state that in the opinion of the Investigator would interfere with the treatment, or healing process.
- Participation in a study of another device or drug within 1 month prior to study enrollment or during this study, and as per the Investigator's careful discretion, as long as not contradictory to any of the above criteria.
- Tattoos in the treatment area.
- Mentally incompetent, prisoner or evidence of active substance or alcohol abuse.
- Having any stage 3-4 cystocele, rectocele, enterocele paravaginal defect or major pelvic organ prolapse beyond the hymenal ring.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of the Safety and Efficacy of Using Multi-Polar Radio Frequency and Pulsed Electromagnetic Field Therapy Technologies for the Treatment of the Mon Pubis, Vaginal Introitus and Labia Skin Laxity
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.
Read the detailed description
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.
- Conditions
- Skin Laxity
- Being tested
- Venus Freeze Diamond Polar
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venus Freeze Diamond PolarDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Venus Freeze Diamond Polar |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline - Day 1, Follow-up visit - Day 85
Secondary outcomes (3)
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).
Measured: Treatment 1 - Day 1, Treatment 2 - Day 29, Treatment 3 - Day 57
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).
Measured: 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.
Measured: Treatment 1 - Day 1, Treatment 2 - Day 29, Treatment 3 - Day 57, Follow-up visit - Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study start26 Mar 2016
- Primary completion30 Nov 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Skin LaxityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Venus Concept
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph Reiz, Study director, Venus Concept
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02770287
- Sponsor's protocol ID
- CS2815
- Status last verified
- Apr 2020
- First submitted
- 9 May 2016
- Last updated
- 17 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Safety and Efficacy of Using Multi-Polar Radio Frequency and Pulsed Electromagnetic Field Therapy Technologies for the Treatment of the Mon Pubis, Vaginal Introitus and Labia Skin Laxity
- ClinicalTrials.gov ID
- NCT02770287
- Acronym / sponsor ID
- CS2815
- Conditions
- Skin Laxity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Venus ConceptIndustry (pharma, biotech, devices)
- Study start
- 26 Mar 2016 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 12 May 2016 (estimated)
- Results
- Posted 2 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Venus Freeze Diamond Polar treatment | Experimental | Device: Venus Freeze Diamond PolarSubjects will receive three treatments with the study device, at four week intervals, followed by a one month follow-up visit after the last treatment. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy female between the ages of 25 and 65.
- Able to read, understand and voluntarily provide written Informed Consent;
- Able and willing to comply with the treatment/follow-up schedule and requirements;
- Fitzpatrick skin type I-VI.
- Sexual activity (vaginal intercourse once per month) in a monogamous relationship.
Key exclusion criteria (22 listed)
- Pregnant or intending to become pregnant during the course of study. A urine pregnancy test will be given to women of childbearing potential and performed during initial visit.
- Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
- Having a permanent implant in the treated area.
- Prior use of retinoids in treated area within 2 weeks of initial treatment or during the course of the study.
- Use of oral Isotretinoin (Accutane®) within 6 months of initial treatment or during the course of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Venus Freeze Diamond PolarThe 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. | Device | Venus Freeze Diamond Polar treatment |
Primary outcome
General Skin Appearance of Mons Pubis and Labia
Time frame: Baseline - Day 1, Follow-up visit - Day 85
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.
3 secondary outcomes
Visual Analogue Scale (VAS)
Time frame: Treatment 1 - Day 1, Treatment 2 - Day 29, Treatment 3 - Day 57
Visual Analog Scale (VAS)
Time frame: Treatment 1 - Day 1, Treatment 2 - Day 29, Treatment 3 - Day 57
Vaginal pH
Time frame: Treatment 1 - Day 1, Treatment 2 - Day 29, Treatment 3 - Day 57, Follow-up visit - Day 85
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Reiz study director
Venus Concept
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Venus Freeze Diamond Polar in people with Skin Laxity, run by Venus Concept at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General Skin Appearance of Mons Pubis and Labia (time frame: Baseline - Day 1, Follow-up visit - Day 85). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2020.