CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 52 enrolled
Drug / intervention
Clobetasol Propionate 0.05% ointment +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02573883
NCT02573883Phase 3Completed
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A Randomized Trial of Clobetasol Propionate Versus Fractionated CO2 Laser for the Treatment of Lichen Sclerosus (CuRLS)

Medstar Health Research Institute·interventional·Posted Oct 12, 2015·Updated Oct 12, 2021

In Brief

A Phase 3 clinical trial evaluating Fractionated Carbon Dioxide Laser and Clobetasol Propionate 0.05% ointment for Vulvar Lichen Sclerosus. Completed, enrolled 52 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVulvar Lichen Sclerosus
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 12, 2015
Enrollment StartOct 1, 2015
Primary CompletionSep 1, 2019
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 10.7 years ago

Interventions

Fractionated Carbon Dioxide Laserdevice

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.

Clobetasol Propionate 0.05% ointmentdrug

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.