Fractionated CO2 Laser With and Without Clobetasol for Treatment of Vulvar Lichen Sclerosus (VULVIE)
Vulvar Lichen Sclerosus
About this trial
This is an interventional treatment trial for Vulvar Lichen Sclerosus focused on measuring Clobetasol propionate, Fractionated CO2-laser
Eligibility Criteria
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 (for women of childbearing potential, pregnancy testing will be conducted at screening, before each FxCO2 laser treatment and at the end of the study)
- 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.
Sites / Locations
- Kaiser Permanente - Southern California Permanente Medical GroupRecruiting
- MedStar HealthRecruiting
- University of Chicago
- Walter Reed National Military Medical CenterRecruiting
- Massachusetts General Hospital
- The University of New MexicoRecruiting
- Columbia UniversityRecruiting
- Ohio State University
- The Institute for Female Pelvic Medicine & Reconstructive SurgeryRecruiting
- Waukesha Memorial HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Clobetasol Group
Placebo Group
Clobetasol propionate 0.05% ointment is the active treatment arm that will be use in women with lichen sclerosus in the study per standard clinical recommendations. Participants will be instructed to apply 0.25-0.5g of the ointment to the affected tissues nightly for 4 weeks starting after the initial FxCO2 laser treatment, then 2 times a week for the remainder of the study (until final study visit).
Placebo ointment is the control treatment arm. Participants will be instructed to apply 0.25-0.5g of the ointment to the affected tissues nightly for 4 weeks starting after the initial FxCO2 laser treatment, then 2 times a week for the remainder of the study (until final study visit).