← Back to Search

Corticosteroid

Topical steroid for Vulvar Lichen Sclerosus

Phase 2 & 3
Recruiting
Led By Charles Hanes, MD
Research Sponsored by University of South Alabama
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
women with biopsy proven lichen sclerosus and significant symptoms based on Skindex-29 scores >21
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up scored by the provider at 6 months
Awards & highlights

Study Summary

This trial will compare the effectiveness of a laser treatment combined with a topical steroid versus just the topical steroid alone in treating lichen sclerosus.

Who is the study for?
This trial is for women who have been diagnosed with lichen sclerosus, confirmed by a biopsy. They should be experiencing significant symptoms as measured by a specific score (Skindex-29 >21).Check my eligibility
What is being tested?
The study is testing if using a fractionated CO2 laser treatment called MonaLisa Touch along with topical steroids improves symptoms of lichen sclerosus better than just using topical steroids alone.See study design
What are the potential side effects?
Potential side effects may include skin irritation, redness, swelling at the site of laser application or steroid use. The severity and occurrence can vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~scored by the provider at 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and scored by the provider at 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Skindex-29 score
Secondary outcome measures
Change in Objective Visual Analog Scale
Change in Vulvovaginal Symptoms Questionnaire (VSQ) score (Total Score)
Change in Vulvovaginal Symptoms Questionnaire score (Emotion Component only)
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Fractionated CO2 laser plus topical steroidsExperimental Treatment2 Interventions
3 laser treatments at 6 week intervals for 6 months by a single trained operator
Group II: topical steroids aloneActive Control1 Intervention
self-applied topical steroid therapy using clobetasol propionate 0.05%
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Topical steroid
2020
Completed Phase 1
~140
MonaLisa Touch
2017
N/A
~40

Find a Location

Who is running the clinical trial?

University of South AlabamaLead Sponsor
42 Previous Clinical Trials
15,882 Total Patients Enrolled
Charles Hanes, MDPrincipal InvestigatorAdjunct Associate Professor of Obstetrics and Gynecology
Stephen Varner, MDPrincipal InvestigatorAssociate Professor of Obstetrics and Gynecology

Frequently Asked Questions

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

How do I sign up for the testing process of this new medication?

"The eligibility requirements for this clinical trial are that participants must have vulvar lichen sclerosus and be between 18-85 years old. Currently, there are 52 potential patients enrolled in the study."

Answered by AI

Can people of an older age group enroll in this clinical trial?

"This study requires that potential participants are adults above the age of 18 and seniors below the age 85."

Answered by AI

Who else is applying?

What site did they apply to?
USA Health Children's and Women's Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Does Steroid Plus CO2 Laser Improve Lichen Sclerosus Symptoms Compared to Steroids Alone?
2022. "Does Steroid Plus CO2 Laser Improve Lichen Sclerosus Symptoms Compared to Steroids Alone?". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05243563.
~16 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top