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

• ClinicalTrials.gov Identifier: NCT03271944
• Recruitment Status: Unknown
• First Posted: September 5, 2017
• Last Update Posted: March 23, 2018
• Sponsor: SHERRY Thomas
• Collaborator: Perigree Medical
• Information provided by (Responsible Party): SHERRY Thomas, The American Association of Female Pelvic Medicine Specialists, Inc.

Study Description

Brief Summary:

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).

Condition or disease	Intervention/treatment	Phase
Vulvovaginal Atrophy	Device: CO2 Laser Treatment	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Fractional Handpiece With CO2 Laser: Fractional Ablative Laser Treatment of Vulvovaginal Atrophy
• Actual Study Start Date: December 29, 2016
• Estimated Primary Completion Date: December 2018
• Estimated Study Completion Date: December 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Fractional handpiece with CO2 laser: Fractional Ablative laser Treatment of Vulvovaginal Atrophy (VVA). [ Time Frame: 9 month ]
   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).

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, California

The American Association of Female Pelvic Medicine Specialists, Inc.; Recruiting

Agoura Hills, California, United States, 91301

Contact: Sherry Thomas, MD 818-991-0988 drsherrythomas@yahoo.com

Contact: Sharan Dhaliwal 8189910988

Principal Investigator: Sherry Thomas, MD

Sponsors and Collaborators

SHERRY Thomas

Perigree Medical

More Information

• Responsible Party: SHERRY Thomas, Principal Investigator, The American Association of Female Pelvic Medicine Specialists, Inc.
• ClinicalTrials.gov Identifier: NCT03271944
• Other Study ID Numbers: 20161370
• First Posted: September 5, 2017
• Last Update Posted: March 23, 2018
• Last Verified: March 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:

Atrophy; Pathological Conditions, Anatomical