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

Purpose

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.

Condition

  • Vulvar Lichen Sclerosus

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Women ≥ 18 years old with biopsy confirmed or clinically diagnosed+ LS - English-speaking or Spanish-speaking - Electing to undergo Fractionated CO2-laser therapy - Willing and able to undergo concomitant 0.05% clobetasol propionate treatment

Exclusion Criteria

  • Prior surgery with placement vaginal mesh for repair of pelvic organ prolapse (does not include vaginal mesh for anti-incontinence procedure "sling" or prior mesh sacrocolpopexy) - Prior laser, topical immunomodulators or systemic therapy for LS - Active genital infection^ - Suspicious vulvar lesion that has not been evaluated - Known vulvar or vaginal malignancy or active treatment for other malignancy - Planning pregnancy or pregnant - Prior pelvic radiation therapy - Topical corticosteroid use on the vulvovaginal tissues in the past 2 weeks* - Contraindication or allergy to clobetasol propionate 0.05% - Currently breast-feeding or lactating - History of poor wound healing, keloids or hypertrophic scarring - History of a skin condition that could interfere with evaluation of efficacy and safety - Eligible for inclusion after washout period of 2 weeks ^Eligible for inclusion after treatment. For patients with known genital HSV we will instruct them to remain on suppression for the duration of the study.

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Clobetasol Group 		Clobetasol propionate 0.05% ointment is the active treatment arm that will be use in women with lichen sclerosus in the study per standard clinical recommendations. Participants will be instructed to apply 0.25-0.5g of the ointment to the affected tissues nightly for 4 weeks starting after the initial FxCO2 laser treatment, then 2 times a week for the remainder of the study (until final study visit).
  • 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
    Other names:
    • Clobetasol
Placebo Comparator
Placebo Group 		Placebo ointment is the control treatment arm. Participants will be instructed to apply 0.25-0.5g of the ointment to the affected tissues nightly for 4 weeks starting after the initial FxCO2 laser treatment, then 2 times a week for the remainder of the study (until final study visit).
  • Device: Fractionated CO2-laser
    All women will be undergoing FxCO2-laser therapy as this treatment is a criterion for enrollment.

More Details

Status
Completed
Sponsor
Medstar Health Research Institute

Study Contact