Advancing Care for Vulvar Lichen Sclerosus: Why the VULVIE Study Matters

At SHE+ Foundation, we believe women deserve answers, innovation, and evidence-based care, especially for conditions that are too often overlooked, underdiagnosed, or dismissed.

That’s why we were proud to help fund the VULVIE Study, a groundbreaking randomized controlled trial examining new treatment possibilities for vulvar lichen sclerosus (VLS), a chronic and often painful condition that affects the vulvar skin and significantly impacts quality of life.

This wasn’t simply a grant. It was an investment in giving women their lives back.

The Society of Gynecologic Surgeons launched this multicenter trial in 2021 with support from SHE+ (formerly Patty Brisben Foundation for Women’s Sexual Health), awarding $171,633 initially, later expanded to $189,563 to support continued enrollment and research progression.

What Is Vulvar Lichen Sclerosus?

Vulvar lichen sclerosus (VLS) is a chronic inflammatory skin disorder that most commonly affects the vulva, causing the tissue to become thin, white, fragile, and prone to tearing.

It is not an infection, nor is it contagious, but it can be devastating to a woman’s quality of life. 

Common symptoms include:

• Severe itching

• Burning and irritation

• Pain during sex

• Pain with urination

• Skin tearing or fissures

• Scarring and narrowing of the vaginal opening

• Changes to vulvar anatomy over time

• Loss of sexual confidence and intimacy

• Emotional distress and decreased quality of life

Many women spend years searching for answers before receiving a diagnosis.

Untreated VLS can lead to progressive scarring and carries an estimated 4–6.7% risk of vulvar squamous cell carcinoma, making early diagnosis and effective treatment critically important.

The Current Standard of Care

The current gold-standard treatment for vulvar lichen sclerosus is topical clobetasol propionate 0.05% ointment, a high-potency corticosteroid used to reduce inflammation and prevent disease progression. For many patients, clobetasol works well. Studies show up to 77% complete symptom remission.

But for many others, symptoms persist, their pain continues, and quality of life remains compromised. That gap is where innovation matters most.

Why the VULVIE Trial Was Needed

Fractional CO2 laser therapy has emerged as a promising treatment option for vulvar conditions because it may improve collagen remodeling, tissue elasticity, vascularization, and symptom relief.

But one major question remained:

Is laser therapy truly more effective when paired with standard steroid treatment?

That question became the foundation of the VULVIE Trial:Vulvar Fractionated CO2-Laser Therapy With and Without Concomitant Topical Clobetasol Propionate 0.05% Ointment for Treatment of Vulvar Lichen Sclerosus.

The goal was simple but powerful: To determine whether combining fractional CO2 laser therapy with clobetasol produces better outcomes than clobetasol alone.

This multicenter randomized controlled trial compared:

Group 1:

Topical clobetasol treatment alone (standard care)

Group 2:

Fractional CO2 laser therapy + topical clobetasol

Researchers evaluated symptom improvement, skin health, sexual well-being, and overall quality of life.

The Long Road to Research

This study reflects something often invisible in research: how hard it is to get women’s health studies off the ground.

The trial required:

• Multiple national research sites

• Institutional Review Board (IRB) approvals

• FDA IND review for compounded clobetasol

• Compounding pharmacy changes

• Clinical hold resolution

• Site-by-site recruitment and enrollment

In 2022, the study was temporarily halted due to FDA review requirements around compounded study medication and an IND application, resulting in a formal clinical hold before enrollment resumed in January 2023.

Instead of stopping, the team pushed forward. In research, persistence matters, because women waiting for care do not have the luxury of delay.

Real Women Were Already Asking for Help

Before outcomes were even published, the need was obvious.

Researchers reported that women were actively finding the study through ClinicalTrials.gov and reaching out for help.

One participant wrote:

“I was recently diagnosed with vulvar lichen sclerosus and am looking into any treatment which may help me live as comfortably as possible with this horrible disease.”

Another shared:

“I have been suffering with LS for quite a few years with no relief or improvement and was hoping to get some more help.”

Enrollment Grew Because the Need Was Real

The trial expanded across multiple sites including MedStar, Walter Reed, University of New Mexico, Kaiser San Diego, and Waukesha.

Enrollment milestones showed just how urgent the demand was:

• 14 participants enrolled within the first two months of active enrollment in 2022

• 33 participants enrolled by April 2023

• 58 participants by July 2023

• 97 randomized by January 2024

• 119 randomized by March 2024—64% of recruitment completed

The original publication later reported 201 total participants randomized, with 103 assigned to the treatment combination and 98 to control.

What the Study Found

The final results were significant.

Patients receiving fractional CO2 laser therapy with clobetasol experienced significantly greater improvement in quality of life and symptom relief compared to those using clobetasol alone.

Researchers found:

• Significant improvement in total Skindex-29 scores

• Better symptom-domain outcomes

• Improved condition-specific quality-of-life measures

• Enhanced vulvar comfort

• Better patient-reported outcomes overall

The study concluded that patients with VLS had improved quality of life after treatment with laser therapy plus clobetasol compared to standard steroid therapy alone. This suggests laser therapy may be a powerful adjunctive treatment, not replacing clobetasol, but improving outcomes for patients who need more.

The Human Impact

One participant described the results this way:

She said the study had allowed her access to laser therapy, which had significantly improved her symptoms and had “given her her life back.”

Another patient, while receiving her first treatment, shared how meaningful it was to know someone was funding research focused on women’s sexual health.

Why SHE+ Funded This Work

At SHE+ Foundation, we fund research that improves real lives. We invest in science that asks harder questions. We support studies that challenge outdated standards. And we believe quality of life belongs at the center of women’s healthcare, not the margins.

The VULVIE Trial reflects exactly that mission.

Why This Matters

Women’s vulvovaginal health has historically been underfunded, under-researched, and under-discussed. Conditions like vulvar lichen sclerosus affect daily life, intimacy, confidence, and long-term health, yet many patients suffer in silence.

Research like the VULVIE trial helps change that. Women deserve treatment plans built around outcomes, not just endurance.

At SHE+ Foundation, we fund research that improves real lives. We support science that asks harder questions, pushes beyond outdated standards, and prioritizes quality of life as much as clinical outcomes.

References:

Dieter A, Gillingham A, Ferrante K, et al. Vulvar Fractionated CO2-Laser Therapy With and Without Concomitant Topical Clobetasol Propionate 0.05% Ointment for Treatment of Vulvar Lichen Sclerosus (VULVIE): A Randomized Controlled Trial. Obstetrics & Gynecology. 2026;147(4S):1S. DOI: 10.1097/AOG.0000000000006204.1.