Fractionated CO2 Laser With and Without Clobetasol for Treatment of Vulvar Lichen Sclerosus
Completed · Phase 4 · Has a placebo group
Conditions studied: Vulvar Lichen Sclerosus
In brief
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.
Key facts
- Study ID
- NCT04951206
- Run by
- Medstar Health Research Institute
- People needed
- 212
- Starts
- 2022-03-01
- Expected to finish
- 2025-04-25
- Last updated by the study team
- 2025-06-05
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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