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

PHASE3CompletedINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

October 31, 2015

Primary Completion Date

September 30, 2019

Study Completion Date

September 30, 2019

Conditions
Vulvar Lichen Sclerosus
Interventions
DEVICE

Fractionated Carbon Dioxide Laser

Vulvar lichen sclerosis will be treated except for the clitoris glans and clitoral hood which will be spared with at least 5mm margin. The procedure will be performed in the outpatient clinic at the National Center for Advanced Pelvic Surgery at MedStar Washington Hospital Center Lafayette Office, 1133 21st St NW, Washington, DC 20036, and include 3 sessions, 4 weeks apart.

DRUG

Clobetasol Propionate 0.05% ointment

Topical Steroid therapy (Clobetasol propionate .05% ointment nightly for one month then three times weekly for 2 additional months) for a total of three months of treatment.

Trial Locations (1)

20010

Medstar Washington Hospital Center Lafayette Office, Washington D.C.

All Listed Sponsors
lead

Medstar Health Research Institute

OTHER