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

Phase 3TerminatedNCT05243563

University of South Alabama11 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Vulvar Lichen Sclerosus

Interventions

MonaLisa TouchDEVICE

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

Topical steroidDRUG

self-applied topical steroid therapy using clobetasol propionate 0.05%

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (2)

USA Health Children's and Women's Hospital

Mobile, Alabama, United States

USA Health Strata Patient Center

Mobile, Alabama, United States

Outcomes

Primary Outcomes

Change in Skindex-29 Score

The Skindex-29 is a validated tool to assess impact of a chronic skin condition on a person's quality of life. It has been previously used to describe the effects of a treatment and to compare treatments. Values range from 1 (Never) to 5 (All the time). The higher the score, the worse the outcome.

Time frame: Completed by the subject at baseline and 6 months.

Secondary Outcomes

Change in Objective Visual Analog Scale

Providers will use this scale to objectively assess vulvar appearance. The tool uses is scored from 0 to 3 (0= absent, 1= mild, 2= moderate, 3= severe) on nine different features of lichen sclerosus (white plaques or hypopigementation, cigarette paper or thin skin, introital narrowing, perianal involvment, loss of labia minora, fusion of labia minora, vulvar fissures, and vulvar erosion). A higher score indicates a higher severity. A higher change in score indicates greater improvement.

Time frame: Scored by the provider at baseline and 6 months

Change in Vulvovaginal Symptoms Questionnaire (VSQ) Score (Total Score)

This 21 item questionnaire assess four aspects impacting quality of life for patients with vulvovaginal skin diseases: symptoms, emotions, life impact and sexual impact. A higher score corresponds to more bothersome symptoms. The values are 0 (No) or 1 (Yes). The higher the score, the worse the outcome. A higher change in these scores indicates more improvement.

Time frame: Administered at baseline and at 6 months by the provider.

Change in Vulvovaginal Symptoms Questionnaire Score (Symptoms Component Only)

A subset of the total score on the VSQ, looking at symptoms only. A higher score corresponds to more bothersome symptoms. The values are 0 (No) or 1 (Yes). The higher the score, the worse the outcome. A higher change in these scores indicates more improvement.

Time frame: Administered at baseline and at 6 months by the provider.

Data from ClinicalTrials.gov

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