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

M

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

Trial contacts and locations

0

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Central trial contact

Alexis Dieter, MD; Melissa Gonzales

Data sourced from clinicaltrials.gov

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