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Fractionated CO2 Laser With and Without Clobetasol for Treatment of Vulvar Lichen Sclerosus

NCT04951206 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2025-06-05

No results posted yet for this study

Summary

This is a randomized placebo-controlled trial design to determine whether combining FxCO2-laser with the traditional therapy of clobetasol propionate 0.05% ointment (combined treatment) as compared to FxCO2-laser and placebo ointment (FxCO2-laser only) will improve treatment response in women undergoing FxCO2-laser for vulvar lichen sclerosus.

Primary objective: To evaluate if women with LS who undergo FxCO2 laser therapy and concomitant TCS (clobetasol group) have higher treatment success (defined as a MCID of a ≥16 point improvement in Skindex-29 questionnaire) than those who undergo FxCO2 laser and placebo ointment (placebo group).

* Hypothesis: A higher proportion of women randomized to clobetasol will achieve treatment success as compared to those randomized to placebo.
* Approach: The proportion of women in each cohort who obtain a ≥16 point improvement in Skindex-29 validated questionnaire score from baseline to final visit will be compared.

Secondary objectives: To compare change in pre- and post-treatment scores on validated questionnaires measuring vulvovaginal symptoms, sexual function, lower urinary tract function, and genital self-image between the clobetasol group compared to the placebo group.

* Hypothesis: Women randomized to clobetasol will demonstrate an equal or greater improvement on validated quality of life questionnaires measuring vulvovaginal symptoms, sexual function, lower urinary tract function, and genital self-image as compared to women randomized to placebo.
* Approach: Change scores will be calculated to determine change per participant over the treatment period and mean change scores will be compared between cohorts.

Conditions

  • Vulvar Lichen Sclerosus

Interventions

DEVICE

Fractionated CO2-laser

All women will be undergoing FxCO2-laser therapy as this treatment is a criterion for enrollment.

DRUG

Clobetasol Propionate 0.05% Ointment

Clobetasol propionate 0.05% ointment obtained from a commercial manufacturer

Sponsors & Collaborators

  • Patty Brisben Foundation For Women's Sexual Health

    collaborator OTHER

  • Society of Gynecologic Surgeons

    collaborator UNKNOWN

  • Medstar Health Research Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2025-04-25
Completion
2025-04-25
FDA Drug
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 NCT04951206 on ClinicalTrials.gov