Does Steroid Plus CO2 Laser Improve Lichen Sclerosus Symptoms Compared to Steroids Alone? (NCT05243563) | Clinical Trial Compass
TerminatedPhase 2/3
Does Steroid Plus CO2 Laser Improve Lichen Sclerosus Symptoms Compared to Steroids Alone?
Stopped: Inability to obtain recruitment levels needed for study to continue.
United States11 participantsStarted 2022-04-13
Plain-language summary
This study will compare the effects of fractionated CO2 laser plus topical steroids versus topical steroids alone in treatment of lichen sclerosus.
Who can participate
Age range
18 Years – 85 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.
Inclusion Criteria:
* women with biopsy proven lichen sclerosus and significant symptoms based on Skindex-29 scores \>21
Exclusion Criteria:
* prior vaginal mesh or pelvic radiation
* active genital infection
* Current or past gynecologic malignancy
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.
1This trial was terminated before it finished — do you know why it was stopped, and does that affect whether the CO2 laser plus steroid combination is something we should still consider for my vulvar lichen sclerosus?
2Since this study was measuring quality-of-life changes using a skin-specific score called the Skindex-29, what does the partial data collected so far actually suggest about whether adding CO2 laser to steroids meaningfully improves symptoms compared to steroids alone?
3Given that this was a Phase 2/3 trial that didn't complete, how confident can we be about the safety profile of combining CO2 laser treatment with topical steroids for lichen sclerosus at this point?
4Would starting with standard steroid treatment alone make more sense for me right now, given that this combination trial was terminated and may not have produced enough evidence to change current practice?
5Are there other active or completed trials, or any clinics with real-world experience using CO2 laser for vulvar lichen sclerosus, that might give us better information to guide my treatment options?
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
1
Change in Skindex-29 Score
Timeframe: Completed by the subject at baseline and 6 months.