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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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 Labi

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.

Detailed Summary:

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.


Sponsor: Venus Concept

Current Primary Outcome: General Skin Appearance [ Time Frame: 3 months ]

General skin appearance improvement at follow up 3 compared to baseline as assessed by independent blinded evaluator by photographic assessment, utilizing the Global Aesthetic Improvement Scale.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Subject's assessment of pain [ Time Frame: 3 months ]
    Subject's assessment of pain associated with treatments using a visual analog scale following each of the 3 treatments.
  • Subject's satisfaction [ Time Frame: 3 months ]
    Subject's satisfaction with the results and assessment of improvement in skin appearance using a Global Aesthetic Improvement scale.
  • Vaginal pH [ Time Frame: 3 months ]
    Subject's vaginal pH with results from pH paper sampling of the vaginal mucosa.
  • Pathology [ Time Frame: 3 months ]
    Subject's histologic and molecular pathology changes with standard molecular histopathology methods.


Original Secondary Outcome: Same as current

Information By: Venus Concept

Dates:
Date Received: May 9, 2016
Date Started: March 8, 2016
Date Completion: June 30, 2017
Last Updated: May 10, 2017
Last Verified: May 2017