NCT04951206

Fractionated CO2 Laser With and Without Clobetasol for Treatment of Vulvar Lichen Sclerosus

A Randomized Controlled Trial of Vulvar Fractionated CO2-Laser Therapy With and Without Concomitant Topical Clobetasol Propionate 0.05% Ointment for Treatment of Vulvar Lichen Sclerosus

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 212 (actual)
• Sponsor: Medstar Health Research Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized placebo-controlled trial design to determine whether combining FxCO2-laser with the traditional therapy of clobetasol propionate 0.05% ointment (combined treatment) as compared to FxCO2-laser and placebo ointment (FxCO2-laser only) will improve treatment response in women undergoing FxCO2-laser for vulvar lichen sclerosus. Primary objective: To evaluate if women with LS who undergo FxCO2 laser therapy and concomitant TCS (clobetasol group) have higher treatment success (defined as a MCID of a ≥16 point improvement in Skindex-29 questionnaire) than those who undergo FxCO2 laser and placebo ointment (placebo group). * Hypothesis: A higher proportion of women randomized to clobetasol will achieve treatment success as compared to those randomized to placebo. * Approach: The proportion of women in each cohort who obtain a ≥16 point improvement in Skindex-29 validated questionnaire score from baseline to final visit will be compared. Secondary objectives: To compare change in pre- and post-treatment scores on validated questionnaires measuring vulvovaginal symptoms, sexual function, lower urinary tract function, and genital self-image between the clobetasol group compared to the placebo group. * Hypothesis: Women randomized to clobetasol will demonstrate an equal or greater improvement on validated quality of life questionnaires measuring vulvovaginal symptoms, sexual function, lower urinary tract function, and genital self-image as compared to women randomized to placebo. * Approach: Change scores will be calculated to determine change per participant over the treatment period and mean change scores will be compared between cohorts.

Conditions

• Vulvar Lichen Sclerosus

Interventions

Type	Name	Description
DEVICE	Fractionated CO2-laser	All women will be undergoing FxCO2-laser therapy as this treatment is a criterion for enrollment.
DRUG	Clobetasol Propionate 0.05% Ointment	Clobetasol propionate 0.05% ointment obtained from a commercial manufacturer

Timeline

• Start date: 2022-03-01
• Primary completion: 2025-04-25
• Completion: 2025-04-25
• First posted: 2021-07-06
• Last updated: 2025-06-05

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study