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: 0
• Participant gender: Female

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medstar Health Research Institute
• Collaborators: Patty Brisben Foundation For Women's Sexual Health; Society of Gynecologic Surgeons
• Treatments: Clobetasol

Criteria

Inclusion Criteria:

• Women with biopsy confirmed or clinically suspected LS

• English-speaking

• Electing to undergo Fractionated CO2-laser therapy

• Willing and able to undergo concomitant 0.05% clobetasol propionate treatment

Exclusion Criteria:

• Prior surgery with placement vaginal mesh for repair of pelvic organ prolapse (does not include vaginal mesh for anti-incontinence procedure "sling" or prior mesh sacrocolpopexy)

• Prior laser, topical immunomodulators or systemic therapy for LS

• Active genital infection^

• Suspicious vulvar lesion that has not been evaluated

• Known vulvar or vaginal malignancy or active treatment for other malignancy

• Planning pregnancy

• Prior pelvic radiation therapy

• Topical corticosteroid use on the vulvovaginal tissues in the past 2 weeks*

• Contraindication or allergy to clobetasol propionate 0.05%

• Eligible for inclusion after washout period of 2 weeks ^Eligible for inclusion after treatment