Radiofrequency and Pulsed Electromagnetic Field Treatment of Skin Laxity of the Mon Pubis, Labia … (NCT02770287) | Clinical Trial Compass
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 range25 Years – 65 Years
SexFEMALE
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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.
✕. Prior use of retinoids in treated area within 2 weeks of initial treatment or during the course of the study.
✕. Use of oral Isotretinoin (Accutane®) within 6 months of initial treatment or during the course of the study.
What they're measuring
1
General Skin Appearance of Mons Pubis and Labia
Timeframe: Baseline - Day 1, Follow-up visit - Day 85
✕. Patient on systemic corticosteroid therapy 6 months prior to and throughout the course of the study.
✕. Prior skin treatment with laser in treated area within 6 months of initial treatment or during the course of the study.
✕. Prior use of collagen, fat injections and /or other methods of skin augmentation (enhancement with injected or implanted material) in treated area within 4-6 weeks of initial treatment or during the course of the study. Treatment may not be performed at all over permanent dermal implants.