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Does Steroid Plus CO2 Laser Improve Lichen Sclerosus Symptoms Compared to Steroids Alone?

NCT05243563 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2025-06-18

Study results available
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Summary

This study will compare the effects of fractionated CO2 laser plus topical steroids versus topical steroids alone in treatment of lichen sclerosus.

Conditions

  • Vulvar Lichen Sclerosus

Interventions

DEVICE

MonaLisa Touch

3 laser treatments at 6 week intervals for 6 months by a single trained operator

DRUG

Topical steroid

self-applied topical steroid therapy using clobetasol propionate 0.05%

Sponsors & Collaborators

  • University of South Alabama

    lead OTHER

Principal Investigators

  • Charles Hanes, MD · Adjunct Associate Professor of Obstetrics and Gynecology

  • Stephen Varner, MD · Associate Professor of Obstetrics and Gynecology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-13
Primary Completion
2024-06-03
Completion
2024-06-03
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05243563 on ClinicalTrials.gov