- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02704741
Clinical Study of the CO2RE Laser Device Performance for Vaginal Atrophy Treatments
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.
Study Overview
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Florida
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Jacksonville, Florida, United States, 32207
- FamWell.MD
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Kentucky
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Louisville, Kentucky, United States, 40205
- 6400 Dutchmans Pkwy Ste 335 Louisville, KY 40205 US
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Massachusetts
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Wayland, Massachusetts, United States, 01778
- Syneron-Candela Institute for Excellence
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New York
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New York, New York, United States, 10028
- Dermatology and Laser Surgery Center of New York
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects seeking treatment of Vaginal Atrophy in the vagina area (External - vestibule and introitus; Internal - Vaginal canal)
- 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.
- Absence of menstruation for at least 12 months
- Not responding to or satisfied with previous local estrogen therapy
- Desire to maintain sexual activity
- Informed consent process completed and subject signed consent
- Willing to receive the proposed CO2RE treatment and follow-up protocol
- Post-menopausal or surgically sterilized.
- Normal cell cytology (PAP smear)
- Negative urinalysis and a normal vaginal canal (no evidence of dysplasia and occult or active infection)
- The external vaginal area (vestibule and introitus) free of injuries and bleeding
- Subject experienced sexual activity at least once a month
Exclusion Criteria:
- Subject had surgery or any other procedure for Vaginal Tightening in the last 12 months
- Use of hormone replacement therapy, either systemic or local within the last 6 months prior to study
- Lubricants or any localized preparation in the 30 days prior to enrollment
- Patient with history of herpes.
- Acute or recurrent urinary tract infection (UTI) or genital infection (e.g. herpes, candida)
- Active malignancy or history of malignancy in the past 5 years
- Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator
- 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)
- 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)
- History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications
- Suffering from hormonal imbalance, whether related to thyroid, pituitary, or androgen
- History of significant lymphatic drainage problems
- History of cancer which required lymph node biopsy or dissection
- 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
- History of keloid scarring, abnormal wound healing and / or prone to bruising
- History of epidermal or dermal disorders (particularly if involving collagen or microvascularity), including collagen vascular disease or vasculitic disorders
- Use of isotretinoin (Accutane®) within 6 months of treatment or during the study
- Subject on systemic corticosteroid therapy 6 months prior to and throughout the course of the study
- Dysplastic nevi in the area to be treated
- 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
- As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study
- Prolapse staged >_ II, according to the pelvic organ prolapse quantification (ICS-POP-Q) system
- Previously undergone pelvic reconstructive surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: all subjects
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. |
The CO2RE system device is intended for dermatological procedures requiring ablation, coagulation and resurfacing of soft tissue, including skin
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in Vulvovaginal Symptom Questionnaire
Time Frame: Baseline, 1 , 2 , 3, 5, 8, and 14 months
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Vulvovaginal Symptom Questionnaire will be used to evaluate improvement of vulvovaginal atrophy symptoms.
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Baseline, 1 , 2 , 3, 5, 8, and 14 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with adverse events
Time Frame: throughout study duration, day 0 up to 17 months
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Number, severity and duration of adverse events following CO2 treatment
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throughout study duration, day 0 up to 17 months
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Vaginal Health Index Improvement
Time Frame: Baseline, 1 , 2 , 3, 5, 8, and 14 months
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Evaluation of vaginal wall conditions such as pH, elasticity, bleeding signs, secretion type and consistency and hydration.
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Baseline, 1 , 2 , 3, 5, 8, and 14 months
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Change from Baseline in Female Sex Function Index
Time Frame: Baseline, 1 , 2 , 3, 5, 8, and 14 months
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Female Sex Function Index will be used to evaluate improvement of vulvovaginal atrophy symptoms
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Baseline, 1 , 2 , 3, 5, 8, and 14 months
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Satisfaction questionnaire
Time Frame: 2 weeks and 1 , 2 , 3, 5, 8, and 14 months
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A questionnaire will be used to evaluate satisfaction with treatment outcome
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2 weeks and 1 , 2 , 3, 5, 8, and 14 months
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Visual analog score for pain
Time Frame: day 0, 4 weeks, 8 weeks
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Patients will complete a visual analog scale to report pain level associated with treatment
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day 0, 4 weeks, 8 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Konika Patel Schallen, MD, Syneron Candela
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DHF19731
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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