Does Steroid Plus CO2 Laser Improve Lichen Sclerosus Symptoms Compared to Steroids Alone?
NCT ID: NCT05243563
Last Updated: 2025-06-18
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2/PHASE3
11 participants
INTERVENTIONAL
2022-04-13
2024-06-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Fractionated CO2 laser plus topical steroids
3 laser treatments at 6 week intervals for 6 months by a single trained operator
MonaLisa Touch
3 laser treatments at 6 week intervals for 6 months by a single trained operator
Topical steroid
self-applied topical steroid therapy using clobetasol propionate 0.05%
topical steroids alone
self-applied topical steroid therapy using clobetasol propionate 0.05%
Topical steroid
self-applied topical steroid therapy using clobetasol propionate 0.05%
Interventions
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MonaLisa Touch
3 laser treatments at 6 week intervals for 6 months by a single trained operator
Topical steroid
self-applied topical steroid therapy using clobetasol propionate 0.05%
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* active genital infection
* Current or past gynecologic malignancy
18 Years
85 Years
FEMALE
No
Sponsors
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University of South Alabama
OTHER
Responsible Party
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Principal Investigators
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Charles Hanes, MD
Role: PRINCIPAL_INVESTIGATOR
Adjunct Associate Professor of Obstetrics and Gynecology
Stephen Varner, MD
Role: PRINCIPAL_INVESTIGATOR
Associate Professor of Obstetrics and Gynecology
Locations
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USA Health Children's and Women's Hospital
Mobile, Alabama, United States
USA Health Strata Patient Center
Mobile, Alabama, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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1731682-3
Identifier Type: -
Identifier Source: org_study_id
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