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

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

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.

Study Overview

• Status: Completed
• Conditions: Vulvar Lichen Sclerosus
• Intervention / Treatment: Device: Fractionated CO2-laser; Drug: Clobetasol Propionate 0.05% Ointment

• Study Type: Interventional
• Enrollment (Actual): 212
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92110
      • Kaiser Permanente - Southern California Permanente Medical Group
  • District of Columbia
    • Washington, District of Columbia, United States, 20036
      • MedStar Health
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
  • Maryland
    • Bethesda, Maryland, United States, 20814
      • Walter Reed National Military Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • The University of New Mexico
  • New York
    • New York, New York, United States, 10032
      • Columbia University
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • The Institute for Female Pelvic Medicine & Reconstructive Surgery
  • Wisconsin
    • Waukesha, Wisconsin, United States, 53188
      • Waukesha Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment success	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.	About 5 months (baseline to final visit)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment response - vulvovaginal symptoms	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.	About 5 months (baseline to final visit)
Treatment response - sexual function	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.	About 5 months (baseline to final visit)
Treatment response - genital self image	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.	About 5 months (baseline to final visit)
Treatment response - lower urinary tract function	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).	About 5 months (baseline to final visit)
Participant-perceived improvement	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."	Final study visit at 4-6 weeks after third Fractionated CO2 laser treatment - one time question
Participant-perceived treatment satisfaction	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".	Final study visit at 4-6 weeks after third Fractionated CO2 laser treatment - one time question

Collaborators and Investigators

• Sponsor: Medstar Health Research Institute
• Collaborators: Patty Brisben Foundation For Women's Sexual Health; Society of Gynecologic Surgeons

Publications and helpful links

General Publications

• Chren MM. The Skindex instruments to measure the effects of skin disease on quality of life. Dermatol Clin. 2012 Apr;30(2):231-6, xiii. doi: 10.1016/j.det.2011.11.003. Epub 2011 Dec 20.
• Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597.
• Herbenick D, Schick V, Reece M, Sanders S, Dodge B, Fortenberry JD. The Female Genital Self-Image Scale (FGSIS): results from a nationally representative probability sample of women in the United States. J Sex Med. 2011 Jan;8(1):158-66. doi: 10.1111/j.1743-6109.2010.02071.x. Epub 2010 Nov 2.
• Herbenick D, Reece M. Development and validation of the female genital self-image scale. J Sex Med. 2010 May;7(5):1822-30. doi: 10.1111/j.1743-6109.2010.01728.x. Epub 2010 Mar 3.
• Hodges KR, Wiener CE, Vyas AS, Turrentine MA. The Female Genital Self-image Scale in Adult Women With Vulvar Lichen Sclerosus. J Low Genit Tract Dis. 2019 Jul;23(3):210-213. doi: 10.1097/LGT.0000000000000481.
• Cella D, Smith AR, Griffith JW, Kirkali Z, Flynn KE, Bradley CS, Jelovsek JE, Gillespie BW, Helfand BT, Talaty P, Weinfurt KP; LURN Study Group. A New Brief Clinical Assessment of Lower Urinary Tract Symptoms for Women and Men: LURN SI-10. J Urol. 2020 Jan;203(1):164-170. doi: 10.1097/JU.0000000000000465. Epub 2019 Jul 31.
• Erekson EA, Yip SO, Wedderburn TS, Martin DK, Li FY, Choi JN, Kenton KS, Fried TR. The Vulvovaginal Symptoms Questionnaire: a questionnaire for measuring vulvovaginal symptoms in postmenopausal women. Menopause. 2013 Sep;20(9):973-9. doi: 10.1097/GME.0b013e318282600b.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): April 25, 2025
• Study Completion (Actual): April 25, 2025

Study Registration Dates

• First Submitted: June 22, 2021
• First Submitted That Met QC Criteria: July 2, 2021
• First Posted (Actual): July 6, 2021

Study Record Updates

• Last Update Posted (Estimated): June 5, 2025
• Last Update Submitted That Met QC Criteria: June 2, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Clobetasol propionate; Fractionated CO2-laser
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Vulvar Diseases; Vulvar Lichen Sclerosus; Lichen Sclerosus et Atrophicus; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Clobetasol
• Other Study ID Numbers: MHRI IRB #STUDY00003851

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No