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

NCT02770287 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2020-04-17

Study results available
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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

Interventions

DEVICE

Venus Freeze Diamond Polar

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.

Sponsors & Collaborators

  • Venus Concept

    lead INDUSTRY

Principal Investigators

  • Joseph Reiz · Venus Concept

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-26
Primary Completion
2017-11-30
Completion
2017-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02770287 on ClinicalTrials.gov