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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 to use a specific skin cream as part of my treatment.
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I speak English or Spanish.
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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.
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I am a woman over 18 with confirmed or suspected Lynch syndrome.
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I am choosing to have CO2-laser therapy.
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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).

Find a Location

Who is running the clinical trial?

Medstar Health Research InstituteLead Sponsor
189 Previous Clinical Trials
115,477 Total Patients Enrolled
1 Trials studying Vulvar Lichen Sclerosus
52 Patients Enrolled for Vulvar Lichen Sclerosus
Patty Brisben Foundation For Women's Sexual HealthOTHER
6 Previous Clinical Trials
211 Total Patients Enrolled
Society of Gynecologic SurgeonsUNKNOWN

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research project currently accepting participants?

"Unfortunately, this trial is no longer accepting new participants. Initially posted on March 1st 2022 and last edited on June 6th 2022, it has since been filled to capacity. However, there are still 10 studies looking for patients with vulvar lichen sclerosus and 5 trials searching for people in the Clobetasol Group that require enrolment at this time."

Answered by AI

What indications are typically managed with Clobetasol Group?

"Clobetasol Group is a popular treatment for alopecia and can also be useful in alleviating other skin conditions such as severe plaque psoriasis, pruritus, and corticosteroid responsive dermatoses."

Answered by AI

What is the anticipated scale of enrollment for this clinical trial?

"The current trial is not seeking additional participants, having been posted on March 1st 2022 and updated most recently on June 6th. Luckily, there are 10 clinical studies actively recruiting for vulvar lichen sclerosus and 5 more trials looking for subjects in the Clobetasol Group."

Answered by AI

Has the Clobetasol Group been granted approval by the FDA?

"The safety of the Clobetasol Group is estimated to be a 3, as it has already cleared Phase 4 trials and been granted approval."

Answered by AI

How many centers are overseeing this trial?

"This medical research is being conducted in multiple locations; namely Columbia University, New york, Waukesha Memorial Hospital, Wisconsin and Northwestern University in Illinois. Additionally 11 other sites are participating as well."

Answered by AI

To what extent has Clobetasol Group been studied in other research trials?

"Clobetasol Group was first studied in 2015 at Toledo Clinic Cancer Centers-Toledo. The treatment has since been tested 53 times, with 5 of those investigations still ongoing. Numerous studies have taken place in New york City alone."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
Texas
Michigan
Other
How old are they?
18 - 65
What site did they apply to?
Massachusetts General Hospital
The University of New Mexico
Houston Methodist
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2

Why did patients apply to this trial?

I would like to do whatever I can to treat my lichens sclerosis. VLS is a devastating condition that affects the very thing that makes me inherently female. I’m willing to commit to anything that can help me have a better quality of life.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

When is this trial starting? How long is the trial and out of pocket cost for me?
PatientReceived 1 prior treatment
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~26 spots leftby Jul 2024