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Fractionated CO2 Laser + Clobetasol for Vulvar Lichen Sclerosus (VULVIE Trial)
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.
VULVIE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowVULVIE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.VULVIE Trial Design
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Who is running the clinical trial?
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- I am allergic or cannot use clobetasol propionate 0.05%.I am willing to use a specific skin cream as part of my treatment.I have a skin condition that might affect treatment results.I had surgery with vaginal mesh for pelvic organ prolapse, not including slings or sacrocolpopexy.You have had problems with healing wounds or developing thick scars in the past.I speak English or Spanish.I am willing and able to use a 0.05% clobetasol propionate treatment.I speak English or Spanish.I have waited 2 weeks after my last treatment to join this study.I have used topical corticosteroids on my vulvovaginal area in the last 2 weeks.I am choosing to have CO2-laser therapy.I am a woman over 18 with confirmed or suspected Lynch syndrome.I have had radiation therapy to my pelvic area before.I am choosing to have CO2-laser therapy.I currently have a genital infection.I am choosing to have CO2-laser therapy.I have had treatments like laser or creams for lichen sclerosus.I have or am being treated for cancer in the vulva or vagina.I have a concerning spot on my vulva that hasn't been checked.
- Group 1: Clobetasol Group
- Group 2: Placebo Group
- 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.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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