13318VULVIEOpenA randomized controlled trial of Vulvar fractionated CO2-Laser therapy with and without concomitant topical clobetasol propionate 0.05% ointment for treatment of Vulvar lichen sclerosusThis is a randomized double-blind 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.NCT04951206InstitutionalAdultTreatmentDevice: Fractionated CO2-laser
Drug: Clobetasol Propionate 0.05% OintmentIVOtherThis study investigates the follow condition or disease: Vulvar Lichen SclerosusDieter, AlexisMedstar Washington Hospital CenterMedStar Medical & Surgical Research Network2026.1.0 Build 16 <a href="https://advarra.com" target="_blank">© 2026 Advarra, Inc.</a>