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Vaginal AtrophyNCT02704741

Clinical Study of the CO2RE Laser Device Performance for Vaginal Atrophy Treatments

A study testing CO2RE in people with Vaginal Atrophy, run by Syneron Medical at 4 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 35 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Vaginal Atrophy
What is being tested?
CO2RE
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
4 sitesUnited States
Study dates
Sep 2015to Sep 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • FamWell.MD

    Jacksonville, Florida, 32207

  • 6400 Dutchmans Pkwy Ste 335 Louisville, KY 40205 US

    Louisville, Kentucky, 40205

  • Dermatology and Laser Surgery Center of New York

    New York, New York, 10028

  • Syneron-Candela Institute for Excellence

    Wayland, Massachusetts, 01778

Other trials in United States

About this study

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.

Read the 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).
Conditions
Vaginal Atrophy
Being tested
CO2RE

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CO2REDevice

    The CO2RE system device is intended for dermatological procedures requiring ablation, coagulation and resurfacing of soft tissue, including skin

Study groups in NCT02704741
Study groupRoleWhat they receive
all subjectsExperimentalEligible 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.
Receives: Device: CO2RE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in Vulvovaginal Symptom Questionnaire

    Vulvovaginal Symptom Questionnaire will be used to evaluate improvement of vulvovaginal atrophy symptoms.

    Measured: Baseline, 1 , 2 , 3, 5, 8, and 14 months

Secondary outcomes (5)

  1. Number of participants with adverse events

    Number, severity and duration of adverse events following CO2 treatment

    Measured: throughout study duration, day 0 up to 17 months

  2. Vaginal Health Index Improvement

    Evaluation of vaginal wall conditions such as pH, elasticity, bleeding signs, secretion type and consistency and hydration.

    Measured: Baseline, 1 , 2 , 3, 5, 8, and 14 months

  3. Change from Baseline in Female Sex Function Index

    Female Sex Function Index will be used to evaluate improvement of vulvovaginal atrophy symptoms

    Measured: Baseline, 1 , 2 , 3, 5, 8, and 14 months

  4. Satisfaction questionnaire

    A questionnaire will be used to evaluate satisfaction with treatment outcome

    Measured: 2 weeks and 1 , 2 , 3, 5, 8, and 14 months

  5. Visual analog score for pain

    Patients will complete a visual analog scale to report pain level associated with treatment

    Measured: day 0, 4 weeks, 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2016 (estimated)
  2. Study startSep 2015
  3. Primary completionJun 2019 (estimated)
  4. Study completionSep 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02704741
Sponsor's protocol ID
DHF19731
Status last verified
Jun 2018
First submitted
28 Feb 2016
Last updated
14 Jun 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

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.

    PubMed 25333211

  • 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.

    PubMed 32329093

Questions about this trial

What is this clinical trial studying?

A study testing CO2RE in people with Vaginal Atrophy, run by Syneron Medical at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Vulvovaginal Symptom Questionnaire (time frame: Baseline, 1 , 2 , 3, 5, 8, and 14 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02704741, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2018.

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