Phase 3 N=52 Randomized Single-blind Treatment

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

Vulvar Lichen Sclerosus

Bottom Line

View on ClinicalTrials.gov: NCT02573883 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2021

Primary outcome: Primary: Change in SkinDEX-29 Score — -16.83; -5.92 score on a scale — p=0.007

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Fractionated Carbon Dioxide Laser (Device); Clobetasol Propionate 0.05% ointment (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Medstar Health Research Institute
Primary completion: Sep 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in SkinDEX-29 Score	-16.83; -5.92	0.007 sig
SECONDARY Change in Subjective Vulvovaginal Symptoms Questionnaire (VSQ)	0.44; 0.3; -1.82; -2.9	—
SECONDARY Change in Subjective Vulvovaginal Symptoms Questionnaire (VSQ)	0.44; 0.3; -1.82; -2.9	—
SECONDARY Number of Participants Considered Satisfied as Assessed by Health Related Quality of Life (HRQOL) Score	14; 4; 9; 10	—
SECONDARY Number of Participants Considered Satisfied as Assessed by Health Related Quality of Life (HRQOL) Score	14; 4; 9; 10	—
SECONDARY Change Vaginal Health Index (VHI) Score	-2.86; 1.44; 1.73; 1.3	—
SECONDARY Change Vaginal Health Index (VHI) Score	-2.86; 1.44; 1.73; 1.3	—
SECONDARY Change Vulvar Symptom Visual Analog Scale (VAS) Score	-0.8; -0.1; -1.82; 0.89; -0.73; -1.5	—
SECONDARY Change Vulvar Symptom Visual Analog Scale (VAS) Score	-0.8; -0.1; -1.82; 0.89; -0.73; -1.5	—
SECONDARY Change SkinDEX-29 Score	-0.78; -7.05; -10.23; -1.52	—
SECONDARY Change Objective Provider VAS Visual Analog Scale	-0.71; -1.25; -0.27; -0.22; 0.07; 0.38	—
SECONDARY Change Objective Provider VAS Visual Analog Scale	-0.71; -1.25; -0.27; -0.22; 0.07; 0.38	—
SECONDARY Number of Patients With Adverse Outcomes	1; 1	—
SECONDARY Number of Patients With Adverse Outcomes	1; 1	—
SECONDARY Number of Patients With Adverse Outcomes	1; 1	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02573883). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.