Vulvar AtrophyVVA PAP POPQNCT07024667
Clinical and Molecular Study to Evaluate the Effect of the Pixel CO2 Laser (FemiLiftTM) for the Treatment of Vulvo-Vaginal Atrophy
A study testing Pixel CO2 Laser for the Treatment of Vulvo-Vaginal Atrophy (VVA) in people with Vulvar Atrophy and Vaginal Atrophy, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
Vulvo Vaginal Atrophy (VVA) refers to the changes in the vaginal and vulvar surfaces that occurs during menopause due to the progressive loss of estrogen. The low levels of circulating estrogen produce a wide variety of anatomic, physiologic, and clinical changes in the urogenital area. Read more about this study
- Who is it for?
- Ages 45 to 75 years, women only
- Conditions the study is for
- Vulvar Atrophy, Vaginal Atrophy
- What is being tested?
- Pixel CO2 Laser for the Treatment of Vulvo-Vaginal Atrophy (VVA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- 2 Sep 2022to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female 45-75 years of age, at the time of enrolment.
- Provided written informed consent.
- Spontaneous induced menopause as defined by one of the followings:
- Amenorrhea of ≥12 months
- After bilateral oophorectomy
- FSH levels>30 IU
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- One or more VVA related symptoms (i.e., itching, dryness, burning, pain, dyspareunia, or dysuria), after other possible causes of these complaints have been excluded.
- Characteristic atrophic changes (see above) on gynaecological examination.
- Normal Papanicolaou (PAP) smear test from the last 3-5 years: if needed and as indicated according to the Israeli guidelines.
- Negative urine analysis test - urine stick.
- Asymptomatic for bacterial or fungal vaginitis.
- Vaginal canal, introitus and vestibule free of injuries and bleeding.
- Able and willing to comply with the treatment/ follow-up schedule and requirements.
- Normal general gynecological exam from the last year including US.
Who cannot join
- Vaginal Health Index Score (VHIS) < 5.
- Active genital infection.
- Vaginal bleeding which did not underwent evaluation.
- Previous vulvar, vaginal or cervical dysplasia, within the last 2 years, or previous cancer.
- Recurring urinary tract infection or recurring infection of genital herpes (≥ 3 episodes in the recent year).
- Pelvic Organ prolapse (POP) >II, according to the pelvic organ prolapse quantification system (POP-Q).
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- Serious systemic disease or any chronic condition that could interfere with study compliance.
- Any local, systemic and/or chronic autoimmune infection.
- Taken part in a clinical trial concerning VVA, within 30 days prior to the enrolment.
- Allergy to lidocaine or tetracaine.
- Genital skin disease that may interfere with the treatment (these subjects should be included/excluded according to the investigator's discretion).
- Use of anticoagulants, within 5 days prior to enrolment.
- Active positive HPV test.
- Active positive HSV (Acute or actively present within the last 2 months).
- Heavy smoker (>1 pack of cigarettes a day)
- Any disease or medication that may interfere with the wound healing/immune function.
- Pregnancy / breast feeding.
- Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the subject safety.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Osnat Palgi mirochnik, RN, BSc contact
Israel1 site, 1 recruiting
- Recruiting
Hille Yaffe Medical Center
Hadera, 3881000
Osnat Palgi Mirochnik, +972-4-7744602, osnatp@hymc.gov.il
About this study
Official title: Clinical and Molecular Study to Evaluate the Effect of the Pixel CO2 Laser (FemiLiftTM) for the Treatment of Vulvo-Vaginal Atrophy (VVA)
Vulvo Vaginal Atrophy (VVA) refers to the changes in the vaginal and vulvar surfaces that occurs during menopause due to the progressive loss of estrogen. The low levels of circulating estrogen produce a wide variety of anatomic, physiologic, and clinical changes in the urogenital area. Clinical symptoms include vaginal dryness, irritation, soreness, dyspareunia, dysuria, and vaginal discharge.
In recent years, microablative fractional CO2 laser has become available for treating vaginal atrophy. It showed a regenerative property with significant histological changes in cellular and connective tissue components. Treatment with the fractional CO2 laser resulted in restoration of the vaginal epithelium with ultrastructural findings, similar to a premenopausal state, that included thickened stratified squamous epithelium with increased collagen support, increased glycogen in epithelial cells, increased fibroblasts, increased vascularity, and presence of sub-epithelial papillae.
Read the detailed description
Vulvo Vaginal Atrophy (VVA) refers to the changes in the vaginal and vulvar surfaces that occurs during menopause due to the progressive loss of estrogen. The low levels of circulating estrogen produce a wide variety of anatomic, physiologic, and clinical changes in the urogenital area. Clinical symptoms include vaginal dryness, irritation, soreness, dyspareunia, dysuria, and vaginal discharge.
In recent years, microablative fractional CO2 laser has become available for treating vaginal atrophy. It showed a regenerative property with significant histological changes in cellular and connective tissue components. Treatment with the fractional CO2 laser resulted in restoration of the vaginal epithelium with ultrastructural findings, similar to a premenopausal state, that included thickened stratified squamous epithelium with increased collagen support, increased glycogen in epithelial cells, increased fibroblasts, increased vascularity, and presence of sub-epithelial papillae.
The aim of the current study is to evaluate the effect of Pixel CO2 laser, (FemiLiftTM), for the treatment of VVA, on the clinical and molecular levels.
- Conditions
- Vulvar Atrophy, Vaginal Atrophy
- Being tested
- Pixel CO2 Laser for the Treatment of Vulvo-Vaginal Atrophy (VVA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pixel CO2 Laser for the Treatment of Vulvo-Vaginal Atrophy (VVA)Device
Pixel CO2 Laser for the Treatment of Vulvo-Vaginal Atrophy (VVA)
| Study group | Role | What they receive |
|---|---|---|
| Study intervention group | Experimental | Patients who has vulvo-vaginal atrophy Receives: Device: Pixel CO2 Laser for the Treatment of Vulvo-Vaginal Atrophy (VVA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of Pixel CO2 laser (FemiLift™) for the treatment of VVA via the patient symptoms and complaints.
The efficacy of Pixel CO2 laser (FemiLift™) treatment will be evaluate by:
- Improvement in VVA symptoms (itching, burning, dryness, dyspareunia, and dysuria) as evaluated by the subject, using a Numeric Rating Scales (NRSs) of 0-10.
- Improvement in sexual function as evaluated by the subject, using the Female Sexual Function Index (FSFI)
Measured: Two years
To evaluate gene expression following the FemiLiftTM treatment
Changes in gene expression profile, 2 weeks following the third FemiLiftTM treatment (Tx3), compared to baseline.
The list of genes chosen for RT PCR following a CO2 laser treatment on vaginal mucosa, includes genes taken from the following biological pathways: inflammatory response, wound healing, extracellular remodeling and connective tissue formation.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start2 Sep 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvar AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jonia Alsheik, MD, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07024667
- Sponsor's protocol ID
- 0001-21-HYMC
- Acronym
- VVA PAP POPQ
- Status last verified
- Jun 2025
- First submitted
- 19 May 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Molecular Study to Evaluate the Effect of the Pixel CO2 Laser (FemiLiftTM) for the Treatment of Vulvo-Vaginal Atrophy (VVA)
- ClinicalTrials.gov ID
- NCT07024667
- Acronym / sponsor ID
- VVA PAP POPQ / 0001-21-HYMC
- Conditions
- Vulvar Atrophy, Vaginal Atrophy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- 2 Sep 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vulvo Vaginal Atrophy (VVA) refers to the changes in the vaginal and vulvar surfaces that occurs during menopause due to the progressive loss of estrogen. The low levels of circulating estrogen produce a wide variety of anatomic, physiologic, and clinical changes in the urogenital area. Clinical symptoms include vaginal dryness, irritation, soreness, dyspareunia, dysuria, and vaginal discharge.
In recent years, microablative fractional CO2 laser has become available for treating vaginal atrophy. It showed a regenerative property with significant histological changes in cellular and connective tissue components. Treatment with the fractional CO2 laser resulted in restoration of the vaginal epithelium with ultrastructural findings, similar to a premenopausal state, that included thickened stratified squamous epithelium with increased collagen support, increased glycogen in epithelial cells, increased fibroblasts, increased vascularity, and presence of sub-epithelial papillae.
Detailed description
Vulvo Vaginal Atrophy (VVA) refers to the changes in the vaginal and vulvar surfaces that occurs during menopause due to the progressive loss of estrogen. The low levels of circulating estrogen produce a wide variety of anatomic, physiologic, and clinical changes in the urogenital area. Clinical symptoms include vaginal dryness, irritation, soreness, dyspareunia, dysuria, and vaginal discharge.
In recent years, microablative fractional CO2 laser has become available for treating vaginal atrophy. It showed a regenerative property with significant histological changes in cellular and connective tissue components. Treatment with the fractional CO2 laser resulted in restoration of the vaginal epithelium with ultrastructural findings, similar to a premenopausal state, that included thickened stratified squamous epithelium with increased collagen support, increased glycogen in epithelial cells, increased fibroblasts, increased vascularity, and presence of sub-epithelial papillae.
The aim of the current study is to evaluate the effect of Pixel CO2 laser, (FemiLiftTM), for the treatment of VVA, on the clinical and molecular levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study intervention group | Experimental | Device: Pixel CO2 Laser for the Treatment of Vulvo-Vaginal Atrophy (VVA)Patients who has vulvo-vaginal atrophy |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Female 45-75 years of age, at the time of enrolment.
- Provided written informed consent.
- Spontaneous induced menopause as defined by one of the followings:
- One or more VVA related symptoms (i.e., itching, dryness, burning, pain, dyspareunia, or dysuria), after other possible causes of these complaints have been excluded.
- Characteristic atrophic changes (see above) on gynaecological examination.
Key exclusion criteria (18 listed)
- Vaginal Health Index Score (VHIS) < 5.
- Active genital infection.
- Vaginal bleeding which did not underwent evaluation.
- Previous vulvar, vaginal or cervical dysplasia, within the last 2 years, or previous cancer.
- Recurring urinary tract infection or recurring infection of genital herpes (≥ 3 episodes in the recent year).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pixel CO2 Laser for the Treatment of Vulvo-Vaginal Atrophy (VVA)Pixel CO2 Laser for the Treatment of Vulvo-Vaginal Atrophy (VVA) | Device | Study intervention group |
Primary outcome
To evaluate the efficacy of Pixel CO2 laser (FemiLift™) for the treatment of VVA via the patient symptoms and complaints.
Time frame: Two years
The efficacy of Pixel CO2 laser (FemiLift™) treatment will be evaluate by: 1. Improvement in VVA symptoms (itching, burning, dryness, dyspareunia, and dysuria) as evaluated by the subject, using a Numeric Rating Scales (NRSs) of 0-10. 2. Improvement in sexual function as evaluated by the subject, using the Female Sexual Function Index (FSFI)
To evaluate gene expression following the FemiLiftTM treatment
Time frame: Two years
Changes in gene expression profile, 2 weeks following the third FemiLiftTM treatment (Tx3), compared to baseline. The list of genes chosen for RT PCR following a CO2 laser treatment on vaginal mucosa, includes genes taken from the following biological pathways: inflammatory response, wound healing, extracellular remodeling and connective tissue formation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
Related trials for Vulvar Atrophy
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Retrospective Cohort Study of Symptoms and Quality of Life in Women With Genitourinary Syndrome of Menopause.
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Laser Vaginal Treatment for GSM
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Changes in the Impact of Genitourinary Syndrome of Menopause With a Novel Nonhormonal Vulvovaginal Gel Assessed by PROMs.
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Efficacy of Collagendep in Reducing Vulvar Dryness in Patients With Lichen Sclerosus Treated With Fat Grafting
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VALOR: Vaginal Atrophy & Long-term Observation of Recovery
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Osnat Palgi mirochnik, RN, BSc contact
Jonia Alsheik, MD principal investigator
Hillel Yaffe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pixel CO2 Laser for the Treatment of Vulvo-Vaginal Atrophy (VVA) in people with Vulvar Atrophy and Vaginal Atrophy, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 14 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonia Alsheik, MD (+972-4-7744602, osnatp@hymc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of Pixel CO2 laser (FemiLift™) for the treatment of VVA via the patient symptoms and complaints. (time frame: Two years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jun 2025.