Radiofrequency and Pulsed Electromagnetic Field Treatment of Skin Laxity of the Mon Pubis, Labia and Vaginal Introitus

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Skin Laxity

Intervention / Treatment
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* Device: Venus Freeze Diamond Polar


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Venus Freeze Diamond Polar treatment<br>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. | Device: Venus Freeze Diamond Polar<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |