At a glance
ClinicalIndex Comparison Record- ✓Healthy female aged 25–65 years
- ✓Fitzpatrick skin types I–VI (all skin types)
- ✓Active sexual intercourse (≥monthly) in monogamous relationship
- ✓Requesting aesthetic benefit to vaginal mons, introitus, and labia
- ✕Pregnant or planning pregnancy during study
- ✕Active electrical implants (pacemaker, defibrillator)
- ✕Permanent implant in treatment area
- ✕Retinoid use within 2 weeks of initial treatment or during study
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A clinical study evaluating Venus Freeze Diamond Polar for Skin Laxity. Completed, enrolled 11 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.