Clinical trial NCT02770287: Radiofrequency and Pulsed Electromagnetic Field Treatment of Skin Laxity of the Mon Pubis, Labia and Vaginal Introitus
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Laxity
Lead sponsor: Venus Concept
Sponsor class: INDUSTRY
First posted: 2016-05-12
Enrollment: 11
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

1. Healthy female between the ages of 25 and 65.
2. Able to read, understand and voluntarily provide written Informed Consent;
3. Able and willing to comply with the treatment/follow-up schedule and requirements;
4. Fitzpatrick skin type I-VI.
5. Sexual activity (vaginal intercourse once per month) in a monogamous relationship.
6. 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.
7. Women requesting aesthetic benefit to the vaginal mons, introitus and labia.

Exclusion Criteria:

1. 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.
2. Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
3. Having a permanent implant in the treated area.
4. Prior use of retinoids in treated area within 2 weeks of initial treatment or during the course of the study.
5. Use of oral Isotretinoin (Accutane®) within 6 months of initial treatment or during the course of the study.
6. Patient on systemic corticosteroid therapy 6 months prior to and throughout the course of the study.
7. Prior skin treatment with laser in treated area within 6 months of initial treatment or during the course of the study.
8. 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.
9. Prior ablative resurfacing procedure in treated area with laser or other devices within 12 months of initial treatment or during the course of the study.
10. Any other surgery in treated area within 12 months of initial treatment or during the course of the study.
11. History of keloid formation or poor wound healing in a previously injured skin area.
12. History of epidermal or dermal disorders (particularly if involving collagen or microvascularity).
13. Open laceration or abrasion of any sort on the area to be treated.
14. Active sexually transmitted disease (e.g. genital Herpes Simplex, condylomata) or vaginosis; any tissue biopsy will be deferred or delayed to a later time point until the infection is resolved.
15. Chronic vulvar pain or vulvar dystrophy.
16. History of immunosuppression/immune deficiency disorders (including human immunodeficiency virus infection or acquired immune deficiency syndrome) or use of immunosuppressive medications.
17. Having any form of active cancer at the time of enrollment and during the course of the study.
18. Significant concurrent illness, such as uncontrolled diabetes i.e. any disease state that in the opinion of the Investigator would interfere with the treatment, or healing process.
19. Participation in a study of another device or drug within 1 month prior to study enrollment or during this study, and as per the Investigator's careful discretion, as long as not contradictory to any of the above criteria.
20. Tattoos in the treatment area.
21. Mentally incompetent, prisoner or evidence of active substance or alcohol abuse.
22. Having any stage 3-4 cystocele, rectocele, enterocele paravaginal defect or major pelvic organ prolapse beyond the hymenal ring.

Primary outcomes:
measure: General Skin Appearance of Mons Pubis and Labia
timeFrame: Baseline - Day 1, Follow-up visit - Day 85
Secondary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: Treatment 1 - Day 1, Treatment 2 - Day 29, Treatment 3 - Day 57
measure: Visual Analog Scale (VAS)
timeFrame: Treatment 1 - Day 1, Treatment 2 - Day 29, Treatment 3 - Day 57
measure: Vaginal pH
timeFrame: Treatment 1 - Day 1, Treatment 2 - Day 29, Treatment 3 - Day 57, Follow-up visit - Day 85
Other outcomes:
Locations:
city: Torrance
country: United States
facility: Revive Wellness Center
state: California
Study officials:
affiliation: Venus Concept
name: Joseph Reiz
role: STUDY_DIRECTOR
References: