Clinical trial NCT02704741: Clinical Study of the CO2RE Laser Device Performance for Vaginal Atrophy Treatments
Official title: Clinical Study of the CO2RE Laser Device Performance for Vaginal Atrophy Treatments
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vaginal Atrophy
Lead sponsor: Syneron Medical
Sponsor class: INDUSTRY
First posted: 2016-03-10
Enrollment: 61
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The CO2RE laser system is a fractional CO2 laser that is FDA approved under a 510(k) K101321 for dermatologic procedures requiring ablation and coagulation of soft tissues, including the skin Eligible subjects will undergo 3 treatments in 4±1 weeks interval on the Vagina (External/Vulva and Internal/Vagina) with the CO2RE device according to study protocol.

Subject will return for to 5 follow-up (FU) visits: 1 week ± 2 days post first treatment visit and 1, 3, 6 and 12 months after last (third) treatment (± 2 weeks).

Methodology described in protocol to evaluate efficacy of treatments will be carried out at each visit at the clinic.

Detailed description: This study is a Prospective clinical study to demonstrate the CO2RE laser device for safety and efficacy for Vaginal Atrophy.

Up to a total of 60 healthy candidates, seeking vaginal treatment from the participating investigator will be enrolled at a participating study site. Subjects will receive three (3) CO2RE treatments.

Each subject will be followed for additional 5 post treatment visits (FU visits) that will be conducted at:

* One week post first treatment - 1wk FU ± 2 days (Safety).
* 1 month post last treatment - 1m FU ± 2 weeks (efficacy \& Safety).
* 3 months post last treatment - 3m FU ± 2 weeks (efficacy \& Safety).
* 6 months post last treatment - 6m FU ± 2 weeks (efficacy \& Safety).
* 12 months post last treatment - 12m FU ± 2 weeks (efficacy \& Safety).

Eligibility criteria: Inclusion Criteria:

1. Subjects seeking treatment of Vaginal Atrophy in the vagina area (External - vestibule and introitus; Internal - Vaginal canal)
2. Healthy female subjects age greater than or equal to 35 years of age who are post menopausal for at least one year, for any reason whether surgical , chemical or natural.
3. Absence of menstruation for at least 12 months
4. Not responding to or satisfied with previous local estrogen therapy
5. Desire to maintain sexual activity
6. Informed consent process completed and subject signed consent
7. Willing to receive the proposed CO2RE treatment and follow-up protocol
8. Post-menopausal or surgically sterilized.
9. Normal cell cytology (PAP smear)
10. Negative urinalysis and a normal vaginal canal (no evidence of dysplasia and occult or active infection)
11. The external vaginal area (vestibule and introitus) free of injuries and bleeding
12. Subject experienced sexual activity at least once a month

Exclusion Criteria:

1. Subject had surgery or any other procedure for Vaginal Tightening in the last 12 months
2. Use of hormone replacement therapy, either systemic or local within the last 6 months prior to study
3. Lubricants or any localized preparation in the 30 days prior to enrollment
4. Patient with history of herpes.
5. Acute or recurrent urinary tract infection (UTI) or genital infection (e.g. herpes, candida)
6. Active malignancy or history of malignancy in the past 5 years
7. Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator
8. Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), lupus, porphyria, or pertinent neurological disorders (i.e. any disease state that in the opinion of the Physician would interfere with the treatment, or healing process)
9. Having a known anticoagulative or thromboembolic condition or taking anticoagulation medications one week prior to and during the treatment course (to allow inclusion, temporary cessation of use as per the subject's physician discretion)
10. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications
11. Suffering from hormonal imbalance, whether related to thyroid, pituitary, or androgen
12. History of significant lymphatic drainage problems
13. History of cancer which required lymph node biopsy or dissection
14. Suffering from significant conditions in the treated areas or inflammatory conditions, including, but not limited to, open lacerations or abrasions of the treatment area prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatment course
15. History of keloid scarring, abnormal wound healing and / or prone to bruising
16. History of epidermal or dermal disorders (particularly if involving collagen or microvascularity), including collagen vascular disease or vasculitic disorders
17. Use of isotretinoin (Accutane®) within 6 months of treatment or during the study
18. Subject on systemic corticosteroid therapy 6 months prior to and throughout the course of the study
19. Dysplastic nevi in the area to be treated
20. Participation in a study of another device or drug within 6 month prior to enrollment or during this study, if treatments of vagina were involved
21. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study
22. Prolapse staged \>_ II, according to the pelvic organ prolapse quantification (ICS-POP-Q) system
23. Previously undergone pelvic reconstructive surgery

Primary outcomes:
measure: Change from Baseline in Vulvovaginal Symptom Questionnaire
timeFrame: Baseline, 1 , 2 , 3, 5, 8, and 14 months
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: throughout study duration, day 0 up to 17 months
measure: Vaginal Health Index Improvement
timeFrame: Baseline, 1 , 2 , 3, 5, 8, and 14 months
measure: Change from Baseline in Female Sex Function Index
timeFrame: Baseline, 1 , 2 , 3, 5, 8, and 14 months
measure: Satisfaction questionnaire
timeFrame: 2 weeks and 1 , 2 , 3, 5, 8, and 14 months
measure: Visual analog score for pain
timeFrame: day 0, 4 weeks, 8 weeks
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: FamWell.MD
state: Florida
city: Louisville
country: United States
facility: 6400 Dutchmans Pkwy Ste 335 Louisville, KY 40205 US
state: Kentucky
city: Wayland
country: United States
facility: Syneron-Candela Institute for Excellence
state: Massachusetts
city: New York
country: United States
facility: Dermatology and Laser Surgery Center of New York
state: New York
Study officials:
affiliation: Syneron Candela
name: Konika Patel Schallen, MD
role: STUDY_DIRECTOR
References:
citation: Salvatore S, Nappi RE, Parma M, Chionna R, Lagona F, Zerbinati N, Ferrero S, Origoni M, Candiani M, Leone Roberti Maggiore U. Sexual function after fractional microablative CO(2) laser in women with vulvovaginal atrophy. Climacteric. 2015 Apr;18(2):219-25. doi: 10.3109/13697137.2014.975197. Epub 2014 Dec 16.
citation: Alexiades MR. Fractional Co2 Laser Treatment of the Vulva and Vagina and the Effect of Postmenopausal Duration on Efficacy. Lasers Surg Med. 2021 Feb;53(2):185-198. doi: 10.1002/lsm.23247. Epub 2020 Apr 23.