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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 belowSelect...
I am willing and able to use a 0.05% clobetasol propionate treatment.
Select...
I speak English or Spanish.
Select...
I am choosing to have CO2-laser therapy.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am allergic or cannot use clobetasol propionate 0.05%.
Select...
I had surgery with vaginal mesh for pelvic organ prolapse, not including slings or sacrocolpopexy.
Select...
I have had radiation therapy to my pelvic area before.
Select...
I currently have a genital infection.
Select...
I have had treatments like laser or creams for lichen sclerosus.
Select...
I have or am being treated for cancer in the vulva or vagina.
Select...
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)
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 moreAwards & 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.
Topical Corticosteroids in the Treatment of Vulvar Lichen Sclerosus: A Review of Pharmacokinetics and Recommended Dosing Frequencies.Lichen sclerosus. Therapy with clobetasol propionate.
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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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am allergic or cannot use clobetasol propionate 0.05%.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 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 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 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.
Research Study Groups:
This trial has the following groups:- Group 1: Clobetasol Group
- Group 2: Placebo Group
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- 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.
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