Overview

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