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NCT Number: NCT04951206

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

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.

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Key information

Conditions

Vulvar Lichen Sclerosus Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases Vulvar Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Kaiser Permanente - Southern California Permanente Medical Group, San Diego, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fractionated CO2-laser

Device

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

clobetasol propionate 0.05% ointment

Drug

Clobetasol propionate 0.05% ointment obtained from a commercial manufacturer

Other names: Clobetasol

Primary outcomes

  1. Treatment success

    Time frame: About 5 months (baseline to final visit)

    Minimally clinically important difference of a ≥16 point improvement in Skindex-29 validated questionnaire score. Skindex-29 responses are transformed to a linear scale from 0 (no effect) to 100 (effect experienced all the time), and are reported as three scale scores, corresponding to three domains (symptoms, emotions, and functioning). A reduction in Skindex-29 score of 16 points or more has been shown to indicate what is considered a clinically meaningful improvement.

Secondary outcomes

  1. Treatment response - vulvovaginal symptoms

    Time frame: About 5 months (baseline to final visit)

    Treatment response - vulvovaginal symptoms will be measured by pre- and post-treatment scores on the vulvovaginal Symptoms Questionnaire, a 21-item survey measuring vulvovaginal symptoms in postmenopausal women.

  2. Treatment response - sexual function

    Time frame: About 5 months (baseline to final visit)

    Treatment response - sexual function will be measured by pre- and post-treatment scores on the Female Sexual Function Index, a validated questionnaire to assess sexual function.

  3. Treatment response - genital self image

    Time frame: About 5 months (baseline to final visit)

    Treatment response - genital self image will be measured by pre- and post-treatment scores on the Female Genital Self Image Scale, a validated survey with scores ranging from 7-28 with higher scores indicate a more positive genital self-image.

  4. Treatment response - lower urinary tract function

    Time frame: About 5 months (baseline to final visit)

    Treatment response - lower urinary tract function will be measured by pre- and post-treatment scores on the LURN SI-10, a 10-item questionnaire with scores ranging from 0 to 38 (higher scores = worse symptoms/bother).

  5. Participant-perceived improvement

    Time frame: Final study visit at 4-6 weeks after third Fractionated CO2 laser treatment - one time question

    Patient Global Impression of Improvement (PGI-I): a one single item question that will ask participants to rate their improvement after undergoing treatment on a 7-point Likert scale ranging from "very much worse" to "very much better."

  6. Participant-perceived treatment satisfaction

    Time frame: Final study visit at 4-6 weeks after third Fractionated CO2 laser treatment - one time question

    Level of satisfaction with treatment: a one single item question that will ask participants to rate their level of satisfaction with treatment on a 5-point Likert scale from "very dissatisfied" to "very satisfied".

Sponsors and collaborators

Lead sponsor

Medstar Health Research Institute

Other

Collaborators

  • Patty Brisben Foundation For Women's Sexual Health
  • Society of Gynecologic Surgeons

Registry information

Official study title

A Randomized Controlled Trial of Vulvar Fractionated CO2-Laser Therapy With and Without Concomitant Topical Clobetasol Propionate 0.05% Ointment for Treatment of Vulvar Lichen Sclerosus

Acronym: VULVIE

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 6, 2021
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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