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

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.