Clobetasol Propionate Versus Fractionated Carbon Dioxide Laser for the Treatment of Lichen Sclerosus (NCT02573883) | Clinical Trial Compass
CompletedPhase 3
Clobetasol Propionate Versus Fractionated Carbon Dioxide Laser for the Treatment of Lichen Sclerosus
United States52 participantsStarted 2015-10
Plain-language summary
This study is being done to compare the effects, good and bad, of fractionated CO2 laser treatment and clobetasol propionate .05% ointment on vulvar lichen sclerosus.
Who can participate
Age range18 Years
SexFEMALE
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:
* Biopsy proven symptomatic vulvar lichen sclerosus
* Ability to understand the study, accept randomization and logistically follow-up with scheduled visits
* English Speaking
Exclusion Criteria:
* Known vulvar malignancy
* Pregnancy or planning pregnancy or less than 3 months postpartum
* Premenopausal
* Current or prior diagnosis of any gynecologic malignancy
* Previous pelvic radiation therapy
* Allergy to topical steroid
* Active Urinary Tract Infection (UTI), vulvar infection (candida, herpes, bacterial vaginosis, trichomoniasis or other infection)
* Pelvic organ prolapse \> than Stage 2
* Treatment with systemic immunomodulators, topical calcineurin inhibitors (tacrolimus, pimecrolimus), or vaginal hormonal or vulvar topical steroid use within 2 months of enrollment
* History of transvaginal mesh implant (excluding sling or sacrocolpopexy mesh)
* IUD (Intrauterine Device)
* Skindex-29 overall score \<21, below mildly impaired health related quality of life threshold
What they're measuring
1
Change in SkinDEX-29 Score
Timeframe: Change from baseline score to score at six months