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

NCT ID: NCT05243563

Last Updated: 2025-06-18

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-13

Study Completion Date

2024-06-03

Brief Summary

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

Detailed Description

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Vulvar lichen sclerosus is a common benign skin condition which causes pain and itching. Topical steroids have been the main treatment. A recent study showed that fractionated CO2 laser treatment is non inferior and actually may improve subjective symptoms compared to topical steroids with no serious safety or adverse events. Because steroids reduce risk of vulvar cancer in patients with lichen sclerosus, the investigators hypothesize that steroids in addition to the fractionated laser will provide greater symptom relief while still allowing patient the benefits of steroid treatment.

Conditions

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Vulvar Lichen Sclerosus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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

Group Type EXPERIMENTAL

MonaLisa Touch

Intervention Type DEVICE

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

Topical steroid

Intervention Type DRUG

self-applied topical steroid therapy using clobetasol propionate 0.05%

topical steroids alone

self-applied topical steroid therapy using clobetasol propionate 0.05%

Group Type ACTIVE_COMPARATOR

Topical steroid

Intervention Type DRUG

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

Intervention Type DEVICE

Topical steroid

self-applied topical steroid therapy using clobetasol propionate 0.05%

Intervention Type DRUG

Other Intervention Names

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SMARTXIDE2 clobetasol propionate

Eligibility Criteria

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Inclusion Criteria

* women with biopsy proven lichen sclerosus and significant symptoms based on Skindex-29 scores \>21

Exclusion Criteria

* prior vaginal mesh or pelvic radiation
* active genital infection
* Current or past gynecologic malignancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of South Alabama

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

USA Health Strata Patient Center

Mobile, Alabama, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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1731682-3

Identifier Type: -

Identifier Source: org_study_id

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