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

Phase 4
Recruiting
Research Sponsored by Medstar Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Willing and able to undergo concomitant 0.05% clobetasol propionate treatment
English-speaking or Spanish-speaking
Timeline
Screening 3 weeks
Treatment Varies
Follow Up about 5 months (baseline to final visit)
Awards & highlights

VULVIE Trial Summary

This trial is designed to see if the traditional therapy of clobetasol combined with FxCO2-laser therapy is more effective than just FxCO2-laser therapy alone in women with vulvar lichen sclerosus.

Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Potential side effects may include typical reactions associated with topical steroids such as thinning of the skin or irritation at the site of application. Laser treatment could cause discomfort during the procedure and possible redness or swelling afterwards.

VULVIE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am willing and able to use a 0.05% clobetasol propionate treatment.
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I speak English or Spanish.
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I am choosing to have CO2-laser therapy.

VULVIE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~about 5 months (baseline to final visit)
This trial's timeline: 3 weeks for screening, Varies for treatment, and about 5 months (baseline to final visit) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Treatment success
Secondary outcome measures
Participant-perceived improvement
Participant-perceived treatment satisfaction
Treatment response - genital self image
+3 more

VULVIE Trial Design

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).

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Who is running the clinical trial?

Society of Gynecologic SurgeonsUNKNOWN
Patty Brisben Foundation For Women's Sexual HealthOTHER
6 Previous Clinical Trials
211 Total Patients Enrolled
Medstar Health Research InstituteLead Sponsor
191 Previous Clinical Trials
117,434 Total Patients Enrolled
1 Trials studying Vulvar Lichen Sclerosus
52 Patients Enrolled for Vulvar Lichen Sclerosus

Media Library

Fractionated CO2-laser Clinical Trial Eligibility Overview. Trial Name: NCT04951206 — Phase 4
Vulvar Lichen Sclerosus Research Study Groups: Clobetasol Group, Placebo Group
Vulvar Lichen Sclerosus Clinical Trial 2023: Fractionated CO2-laser Highlights & Side Effects. Trial Name: NCT04951206 — Phase 4
Fractionated CO2-laser 2023 Treatment Timeline for Medical Study. Trial Name: NCT04951206 — Phase 4
~13 spots leftby Jul 2024