Fractionated CO2 Laser with and Without Clobetasol for Treatment of Vulvar Lichen Sclerosus
- Conditions
- Vulvar Lichen Sclerosus
- Interventions
- Device: Fractionated CO2-laser
- Registration Number
- NCT04951206
- Lead Sponsor
- Medstar Health Research Institute
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 184
- 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
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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^
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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*
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Contraindication or allergy to clobetasol propionate 0.05%
-
Currently breast-feeding or lactating
-
History of poor wound healing, keloids or hypertrophic scarring
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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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Clobetasol Group Clobetasol Propionate 0.05% Ointment 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). Placebo Group Fractionated CO2-laser 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). Clobetasol Group Fractionated CO2-laser 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).
- Primary Outcome Measures
Name Time Method Treatment success 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 Outcome Measures
Name Time Method Treatment response - sexual function 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.
Treatment response - vulvovaginal symptoms 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.
Treatment response - lower urinary tract function 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).
Treatment response - genital self image 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.
Participant-perceived treatment satisfaction 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".
Participant-perceived improvement 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."
Trial Locations
- Locations (10)
Waukesha Memorial Hospital
🇺🇸Waukesha, Wisconsin, United States
Kaiser Permanente - Southern California Permanente Medical Group
🇺🇸San Diego, California, United States
MedStar Health
🇺🇸Washington, District of Columbia, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Walter Reed National Military Medical Center
🇺🇸Bethesda, Maryland, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
The University of New Mexico
🇺🇸Albuquerque, New Mexico, United States
Columbia University
🇺🇸New York, New York, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
The Institute for Female Pelvic Medicine & Reconstructive Surgery
🇺🇸Allentown, Pennsylvania, United States