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Corticosteroid

Steroid + CO2 Laser for Lichen Sclerosus

Phase 2 & 3
Waitlist Available
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
No Placebo-Only Group

Summary

This trial will test if using a special laser along with steroid cream can better relieve pain and itching in patients with vulvar lichen sclerosus compared to using just the steroid cream.

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).
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.
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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Skindex-29 score
Secondary study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
43 Previous Clinical Trials
15,757 Total Patients Enrolled
Charles Hanes, MDPrincipal InvestigatorAdjunct Associate Professor of Obstetrics and Gynecology
Stephen Varner, MDPrincipal InvestigatorAssociate Professor of Obstetrics and Gynecology
~3 spots leftby Nov 2025
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