CompletedNot Applicable

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

United States11 participantsStarted 2016-03-26

Plain-language 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.

Who can participate

Age range

25 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

General Skin Appearance of Mons Pubis and Labia

Timeframe: Baseline - Day 1, Follow-up visit - Day 85

Trial details

NCT IDNCT02770287

SponsorVenus Concept

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-11-30

Results submitted2018-04-06

View on ClinicalTrials.gov More Skin Laxity trials