Clobetasol ointment versus fractional CO2 laser for vulvar lichen sclerosus
Official title: Vulvar Lichen Sclerosus: Expression of Inflammatory Markers in a Randomized Clinical Trial With Clobetasol Versus Laser
Run by Universidade Federal do Rio de Janeiro · NCT07240519 · Data updated 2026-11-12
We are testing whether clobetasol ointment or fractional CO2 laser works better to reduce inflammation and symptoms in women with biopsy-confirmed vulvar lichen sclerosus who have not used topical corticosteroids.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 21 Years and up |
| Sex | Women only |
| Enrollment | 40 (estimated) |
| Sponsor | Universidade Federal do Rio de Janeiro Academic / other |
| Locations | 1 site (Rio de Janeiro, Rio de Janeiro) |
| Status | Recruiting |
| Started | June 22, 2022 |
| Main results expected | September 10, 2025 |
| Study ends | June 2026 |
| Registry record updated | November 26, 2025 |
| Trial ID | NCT07240519 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged over 21 with histologically confirmed vulvar lichen sclerosus who have not used topical corticosteroids and who consent to clinic visits and procedures are ideal candidates.
✕Probably not a fit
Women with other concomitant vulvar diseases, premalignant vulvar lesions, prior pelvic radiotherapy, or prior topical corticosteroid treatment are unlikely to benefit or be eligible for this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized interventional trial compares topical clobetasol ointment against fractional microablative CO2 laser in women with histologically confirmed vulvar lichen sclerosus who have not previously used topical corticosteroids. Forty participants are randomized to receive either a three-month tapering clobetasol regimen or three fractional CO2 laser sessions given four weeks apart. Inflammatory biomarkers and clinical signs and symptoms are measured at baseline and three months after treatment to compare biological and symptomatic responses. The trial is conducted with in-person visits at the Institute of Gynecology of the Federal University of Rio de Janeiro.
Why it matters
Potential benefit: If successful, this could identify an effective nonsteroidal treatment option that reduces symptoms and avoids long-term steroid side effects.
How similar studies have gone: Small case series and nonrandomized studies have reported symptom improvements with fractional CO2 laser in vulvar lichen sclerosus, but randomized comparisons to clobetasol are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Women older than 21 years; histological diagnostic of vulvar lichen sclerosus and no previous treatment with topic corticoesteroid Exclusion Criteria: Women that don't agree in taking part of the study; other concomitant vulvar diseases; pre malignant vulvar disease HPV dependent and independent; previous pelvic radiotherapy \-
Where it's running
-
Institute of Gynecology of the Federal University of Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, Brazil Recruiting
Study contacts
- Principal investigator: Andrea Cytryn, Master of Science in Health — Department of Gynecology, Institute of Gynecology, Federal University of Rio de janeiro
- Study coordinator: Andréa Cytryn, Master Degree
- Email: andreacytryn@hotmail.com
- Phone: +55 21 98123 0332
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.