What side effects are associated with this type of intervention?

The most common treatment for Vulvar Lichen Sclerosus, Clobetasol Propionate 0.05% ointment, is a potent topical corticosteroid that can cause several side effects. These include skin thinning (atrophy), stretch marks (striae), easy bruising, and an increased risk of skin infections. Prolonged use may lead to systemic absorption, potentially resulting in adrenal suppression. Patients should use this medication under close medical supervision to minimize these risks.

What prior FDA approvals exist?

Clobetasol Propionate 0.05% ointment is a potent topical corticosteroid commonly used to treat Vulvar Lichen Sclerosus by reducing inflammation and modulating the immune response. This treatment is well-documented and widely accepted in clinical practice. Other similar treatments include various high-potency topical corticosteroids, which are often the first-line therapy for managing symptoms and preventing disease progression. These treatments aim to alleviate itching, pain, and skin changes associated with the condition.

What other types of research exist?

Promising novel alternatives to Clobetasol Propionate 0.05% Ointment for Vulvar Lichen Sclerosus include Fractionated CO2 (FxCO2) laser therapy, either alone or in combination with other treatments. This approach has shown potential in improving treatment outcomes for patients.

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

Phase 4

Waitlist Available

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ about 5 months (baseline to final visit)

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).

0 / 10Eligibility criteria met

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.