Clobetasol ointment versus fractional CO2 laser for vulvar lichen sclerosus
Vulvar Lichen Sclerosus: Expression of Inflammatory Markers in a Randomized Clinical Trial With Clobetasol Versus Laser
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 21 Years and up |
| Sex | Female |
| Sponsor | Universidade Federal do Rio de Janeiro Academic / other |
| Locations | 1 site (Rio de Janeiro, Rio de Janeiro) |
| Trial ID | NCT07240519 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Rio de Janeiro, Rio de Janeiro
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.