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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).
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.
Enrollment
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Inclusion criteria
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
Primary purpose
Allocation
Interventional model
Masking
184 participants in 2 patient groups, including a placebo group
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Central trial contact
Alexis Dieter, MD; Melissa Gonzales
Data sourced from clinicaltrials.gov
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