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

MHRI IRB #STUDY00003851

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.

2022-03-01

2024-07-30

2025-06-30

Recruiting

Early phase I

184

Inclusion Criteria: * Women ≥ 18 years old with biopsy confirmed or clinically diagnosed+ LS * English-speaking or Spanish-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 or pregnant * Prior pelvic radiation therapy * Topical corticosteroid use on the vulvovaginal tissues in the past 2 weeks\* * Contraindication or allergy to clobetasol propionate 0.05% * Currently breast-feeding or lactating * History of poor wound healing, keloids or hypertrophic scarring * History of a skin condition that could interfere with evaluation of efficacy and safety * Eligible for inclusion after washout period of 2 weeks \^Eligible for inclusion after treatment. For patients with known genital HSV we will instruct them to remain on suppression for the duration of the study.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 184, 'type': 'ESTIMATED'}}

2023-08-22