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

NCT02770287 | Completed Results

• 1 other identifier: CS2815
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Skin Laxity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Visual Analogue Scale (VAS)

  Treatment 1 - Day 1, Treatment 2 - Day 29, Treatment 3 - Day 57

• Visual Analog Scale (VAS)

  Treatment 1 - Day 1, Treatment 2 - Day 29, Treatment 3 - Day 57

• Vaginal pH

  Treatment 1 - Day 1, Treatment 2 - Day 29, Treatment 3 - Day 57, Follow-up visit - Day 85

Study Arms (1)

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.

Device: Venus Freeze Diamond Polar

Interventions

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.

Venus Freeze Diamond Polar treatment

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Venus Concept: lead

Study Sites (1)

Revive Wellness Center

Torrance, California, 90505, United States

Location

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Results Point of Contact

• Title: Yoni Iger
• Organization: Venus Concept Ltd

yoni@venusconcept.com

888-907-0115

Study Officials

• Joseph Reiz

  Venus Concept

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Independent reviewer to identify the four-month photograph of the mons pubis and labia as compared to the baseline (untreated photo).
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2016
• First Posted: May 12, 2016
• Study Start: March 26, 2016
• Primary Completion: November 30, 2017
• Study Completion: November 30, 2017
• Last Updated: April 17, 2020
• Results First Posted: January 2, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)