Fractionated CO2 Laser With and Without Clobetasol for Treatment of Vulvar Lichen Sclerosus
NCT ID: NCT04951206
Last Updated: 2025-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
212 participants
INTERVENTIONAL
2022-03-01
2025-04-25
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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).
Fractionated CO2-laser
All women will be undergoing FxCO2-laser therapy as this treatment is a criterion for enrollment.
Clobetasol Propionate 0.05% Ointment
Clobetasol propionate 0.05% ointment obtained from a commercial manufacturer
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).
Fractionated CO2-laser
All women will be undergoing FxCO2-laser therapy as this treatment is a criterion for enrollment.
Interventions
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Fractionated CO2-laser
All women will be undergoing FxCO2-laser therapy as this treatment is a criterion for enrollment.
Clobetasol Propionate 0.05% Ointment
Clobetasol propionate 0.05% ointment obtained from a commercial manufacturer
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
FEMALE
No
Sponsors
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Patty Brisben Foundation For Women's Sexual Health
OTHER
Society of Gynecologic Surgeons
UNKNOWN
Medstar Health Research Institute
OTHER
Responsible Party
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Locations
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Kaiser Permanente - Southern California Permanente Medical Group
San Diego, California, United States
MedStar Health
Washington D.C., 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
Waukesha Memorial Hospital
Waukesha, Wisconsin, United States
Countries
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References
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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.
Other Identifiers
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MHRI IRB #STUDY00003851
Identifier Type: -
Identifier Source: org_study_id
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