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

Medstar Health Research Institute212 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

212

Conditions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (10)

Kaiser Permanente - Southern California Permanente Medical Group

San Diego, California, United States

MedStar Health

Washington D.C., District of Columbia, United States

University of Chicago

Chicago, Illinois, United States

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

The University of New Mexico

Albuquerque, New Mexico, United States

Columbia University

New York, New York, United States

Ohio State University

Columbus, Ohio, United States

The Institute for Female Pelvic Medicine & Reconstructive Surgery

Allentown, Pennsylvania, United States

Waukesha Memorial Hospital

Waukesha, Wisconsin, United States

Outcomes

Primary Outcomes

Treatment success

Minimally clinically important difference of a ≥16 point improvement in Skindex-29 validated questionnaire score. Skindex-29 responses are transformed to a linear scale from 0 (no effect) to 100 (effect experienced all the time), and are reported as three scale scores, corresponding to three domains (symptoms, emotions, and functioning). A reduction in Skindex-29 score of 16 points or more has been shown to indicate what is considered a clinically meaningful improvement.