Clobetasol Propionate Versus Fractionated Carbon Dioxide Laser for the Treatment of Lichen Sclerosus

• Status: Completed
• Trial end date: 2019-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medstar Health Research Institute
• Treatments: Clobetasol

Criteria

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