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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
Must not have
Contraindication or allergy to clobetasol propionate 0.05%
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up about 5 months (baseline to final visit)
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

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.

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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am allergic or cannot use clobetasol propionate 0.05%.
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I had surgery with vaginal mesh for pelvic organ prolapse, not including slings or sacrocolpopexy.
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I have had radiation therapy to my pelvic area before.
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I currently have a genital infection.
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I have had treatments like laser or creams for lichen sclerosus.
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I have or am being treated for cancer in the vulva or vagina.
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I have a concerning spot on my vulva that hasn't been checked.

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

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

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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).

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Clobetasol Propionate 0.05% ointment is a potent topical corticosteroid that works by reducing inflammation and modulating the immune response in the affected area. This is crucial for patients with Vulvar Lichen Sclerosus because the condition involves chronic inflammation and immune-mediated damage to the vulvar skin, leading to symptoms like itching, pain, and scarring. By decreasing inflammation and immune activity, Clobetasol helps alleviate symptoms, improve skin appearance, and prevent further tissue damage, thereby enhancing the quality of life for patients.
Topical Corticosteroids in the Treatment of Vulvar Lichen Sclerosus: A Review of Pharmacokinetics and Recommended Dosing Frequencies.Lichen sclerosus. Therapy with clobetasol propionate.

Find a Location

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
195 Previous Clinical Trials
182,975 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
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