Fractionated CO2 Laser With and Without Clobetasol for Treatment of Vulvar Lichen Sclerosus
Status:
Not yet recruiting
Trial end date:
2024-06-30
Target enrollment:
Participant gender:
Summary
This 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.
Phase:
Phase 4
Details
Lead Sponsor:
Medstar Health Research Institute
Collaborators:
Patty Brisben Foundation For Women's Sexual Health Society of Gynecologic Surgeons