Fractionated CO2 Laser + Clobetasol for Vulvar Lichen Sclerosus
(VULVIE Trial)

Recruiting in Palo Alto (17 mi)

+11 other locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Medstar Health Research Institute

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests if using a special laser along with a strong anti-inflammatory cream can better treat women with vulvar lichen sclerosus compared to using the laser alone. The laser helps the skin heal by making tiny, controlled injuries, while the cream reduces swelling and itching. Researchers will compare improvements in symptoms and quality of life.

Research Team

Eligibility Criteria

This trial is for English or Spanish-speaking women aged 18 and older with diagnosed vulvar lichen sclerosus, who are willing to undergo CO2-laser therapy and use clobetasol ointment. It's not for those with vaginal mesh from pelvic surgery, active genital infections, prior LS treatments like laser or immunomodulators, undiagnosed vulvar lesions, cancer treatments, pregnancy plans or current pregnancy, recent corticosteroid use on the genitals, known allergies to clobetasol propionate, breastfeeding mothers or certain skin conditions.

Inclusion Criteria

I am willing and able to use a 0.05% clobetasol propionate treatment.

I speak English or Spanish.

I am a woman over 18 with confirmed or suspected Lynch syndrome.

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Exclusion Criteria

I am allergic or cannot use clobetasol propionate 0.05%.

I have a skin condition that might affect treatment results.

I had surgery with vaginal mesh for pelvic organ prolapse, not including slings or sacrocolpopexy.

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Treatment Details

Interventions

Clobetasol Propionate 0.05% Ointment (Corticosteroid)
Fractionated CO2-laser (Procedure)

Trial OverviewThe study tests if combining Fractionated CO2-laser treatment (FxCO2) with a traditional medication (clobetasol propionate ointment) is more effective than FxCO2-laser with placebo in treating vulvar lichen sclerosus. Success is measured by improvement in a quality of life questionnaire score. The study also compares changes in symptoms related to sexual function and self-image between the two groups.

Participant Groups

2Treatment groups

Active Control

Placebo Group

Group I: Clobetasol GroupActive Control2 Interventions

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).

Group II: Placebo GroupPlacebo Group1 Intervention

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).