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

MedStar Health

Status and phase: Enrolling; Phase 4

Conditions: Vulvar Lichen Sclerosus

Treatments: Device: Fractionated CO2-laser; Drug: Clobetasol Propionate 0.05% Ointment

Study type: Interventional

Funder types: Other

Identifiers

NCT04951206

MHRI IRB #STUDY00003851

Details and patient eligibility

About

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.

Enrollment: 184 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

184 participants in 2 patient groups, including a placebo group

Clobetasol Group

Active Comparator group

Description:

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).

Treatment:

Drug: Clobetasol Propionate 0.05% Ointment

Device: Fractionated CO2-laser

Placebo Group

Placebo Comparator group

Description:

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).

Treatment:

Device: Fractionated CO2-laser