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

Status unconfirmed · Not applicable

Conditions studied: Vulvovaginal Atrophy

In brief

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).

Key facts

Study ID

NCT03271944

Run by

SHERRY Thomas

People needed

30

Starts

2016-12-29

Expected to finish

2019-12-01

Last updated by the study team

2018-03-23

Who can join

Age: 40 and older, up to 80. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The American Association of Female Pelvic Medicine Specialists, Inc. — Agoura Hills, California, United States (enrolling)

Full record on ClinicalTrials.gov

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