Fractional Handpiece With CO2 Laser: Fractional Ablative Laser Treatment of Vulvovaginal Atrophy

To assess the feasibility and efficacy of the CO2 fractional handpiece in the treatment of vulvovaginal atrophy (VVA) in post-menopausal women and its effect on the patient VHIS(vaginal health index core). The primary endpoint is to assess the change in the vaginal dryness by means of a visual analogic scale (10 cm VAS).

Study Overview

• Status: Unknown
• Conditions: Vulvovaginal Atrophy
• Intervention / Treatment: Device: CO2 Laser Treatment

Detailed Description

The purpose of this study is to evaluate the use of a CO2 laser (EdgeTM CO2 Laser) with a fractional handpiece made specifically for the vagina to possibly restore the normal physiological conditions of the vagina, thus reducing the symptoms of VVA. The EdgeTM CO2 Laser and general fractional handpiece is approved by the FDA for ablative skin resurfacing (for example, treating fine lines and wrinkles, acne and surgical scars, skin pigmentation and discoloration, sun damage, pre-cancerous as well as benign lesions and uneven skin texture). The fractional handpiece used in this study for the treatment of VVA is experimental and has not been approved by the FDA for vaginal dryness associated with menopause.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Agoura Hills, California, United States, 91301
      • Recruiting
      • The American Association of Female Pelvic Medicine Specialists, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Subjects meeting the following inclusion criteria may participate:

  • Healthy non-smoking post menopausal women with absence of menstruation of at least 12 months
  • Exhibiting VVA symptoms
  • Prolapse staged < II, according to the pelvic organ prolapse quantification (ICS-POP- Q) system
  • Have not had procedures in the anatomical area through 6 months prior to treatment
  • Understand and accept the obligation and is logistically able to present for all scheduled follow-up visits

Exclusion Criteria:

• Subjects meeting any of the following criteria will be excluded from participation:

  • Acute or recurrent urinary tract infection (UTI), or genital infection (e.g. herpes candida).
  • Prolapse staged ≥ II, according to the pelvic organ prolapse quantification (ICS-POP- Q) system
  • Any serious disease, or chronic condition, that could interfere with the study compliance
  • Previously undergone reconstructive pelvic surgery
  • Have used vaginal creams, moisturizers, lubricants or homeopathic preparations for at least 3 months
  • A history of thrombophlebitis
  • A history of acute infections
  • A history of heart failure
  • Received or is anticipated to receive antiplatelets, anticoagulants, thrombolytics, vitamin E or anti inflammatories within 2 weeks pre treatment
  • Any medical condition, that, in the investigator's opinion would interfere with the patient's participation in the study
  • Taking medications that are photosensitive
  • A history of keloid formation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single group 30 post menopause females.	Device: CO2 Laser Treatment; Fractional handpiece with CO2 laser: Fractional Ablative laser Treatment of Vulvovaginal Atrophy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fractional handpiece with CO2 laser: Fractional Ablative laser Treatment of Vulvovaginal Atrophy (VVA).	The purpose of this study is to evaluate efficacy and safety of CO2 laser (EdgeTM CO2 Laser) with a fractional headpiece in the treatment of vulvovaginal atrophy (VVA) in post- menopausal women and its effect on the patient VHIS (vaginal health index score). The primary endpoint is to assess the changes in the vaginal dryness by mean of a visual analog scale (10 cm VAS).	9 month

Collaborators and Investigators

• Sponsor: SHERRY Thomas
• Collaborators: Perigree Medical

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2016
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: August 29, 2017
• First Submitted That Met QC Criteria: September 1, 2017
• First Posted (Actual): September 5, 2017

Study Record Updates

• Last Update Posted (Actual): March 23, 2018
• Last Update Submitted That Met QC Criteria: March 22, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: 20161370

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes