Fractional Handpiece With CO2 Laser: Fractional Ablative Laser Treatment of Vulvovaginal Atrophy
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 40 - 80 |
| Updated: | 4/17/2018 |
| Start Date: | December 29, 2016 |
| End Date: | December 2019 |
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).
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).
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.
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.
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
We found this trial at
1
site
Agoura Hills, California 91301
Principal Investigator: Sherry Thomas, MD
Phone: 818-991-0988
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