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

Skin Laxity Clinical Trial

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

Clinical 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02770287
Study type Interventional
Source Venus Concept
Contact
Status Completed
Phase N/A
Start date March 26, 2016
Completion date November 30, 2017
View Details
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