CompletedNot Applicable

Fractional / Pixel CO2 Laser Treatment of Vulvar Atrophy and Lichen Sclerosus

Israel16 participantsStarted 2017-09-01

Plain-language summary

The study will examine the effects of fractional/pixel CO2 laser treatment in vaginal atrophy and in vulvar lichen sclerosus by means of histological and immuno-histochemical characterization of the epithelial layers and markers of tissue aging. The tissue characterization will be performed by biopsies of the vaginal or vulvar tissue at three different points of time: prior to treatment, two weeks after the third and last treatment, and one year after the last treatment.

Who can participate

Age range

18 Years – 80 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Vaginal Atrophy - Inclusion Criteria * Menopause for more than one year * One or more of the following symptoms: sensation of dryness, itch, irritation, burning, discomfort, dysuria, dyspareunia * Characteristic atrophic changes on gynecological examination * Laboratory workup: pH \>4.5, characteristic microscopic smear (increased number of para-basal cells) * Normal Pap-smear within 12 months * Negative vaginal culture for fungi or relevant bacteria * Negative test for STD pathogens (chlamydia, gonorrhea, genital mycoplasma and trichomonas) Exclusion Criteria * Genital skin disease * Active infection * Pelvic organs prolapse above grade 2 * Previous surgery for pelvic organs prolapse * Use of systemic or local hormonal preparations during 6 months preceding the study treatment * History of malignant diseases * Undiagnosed vaginal bleeding * Use of analgesics or antidepressants * Use of anticoagulants Lichen Sclerosus Inclusion Criteria * Age 18-80 * Biopsy demonstrates characteristic changes for lichen sclerosus * One or more of the following symptoms: sensation of dryness, itch, irritation, burning, discomfort. * Characteristic changes for lichen sclerosus on gynecological examination * Negative vaginal culture for fungi or relevant bacteria * Negative test for STD pathogens (chlamydia, gonorrhea, genital mycoplasma and trichomonas) Exclusion Criteria * Use of steroid-containing creams for the vulvar region two months preceding recruitment * Additional genital skin d…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from baseline of vaginal health index score

Timeframe: T0-Recruitment, T1-2-4 weeks, T2- 6-8 weeks, T3-10-12 weeks, T4-12-14 weeks, T5- 12 months

Trial details

NCT IDNCT03063684

SponsorHadassah Medical Organization

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-12-30

View on ClinicalTrials.gov More Vaginal Atrophy trials