Clinical trial NCT04951206: Fractionated CO2 Laser With and Without Clobetasol for Treatment of Vulvar Lichen Sclerosus
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vulvar Lichen Sclerosus
Keywords: Clobetasol propionate
Fractionated CO2-laser
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
Collaborators: name: Patty Brisben Foundation For Women's Sexual Health
name: Society of Gynecologic Surgeons
First posted: 2021-07-06
Enrollment: 212
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Treatment success
timeFrame: About 5 months (baseline to final visit)
Secondary outcomes:
measure: Treatment response - vulvovaginal symptoms
timeFrame: About 5 months (baseline to final visit)
measure: Treatment response - sexual function
timeFrame: About 5 months (baseline to final visit)
measure: Treatment response - genital self image
timeFrame: About 5 months (baseline to final visit)
measure: Treatment response - lower urinary tract function
timeFrame: About 5 months (baseline to final visit)
measure: Participant-perceived improvement
timeFrame: Final study visit at 4-6 weeks after third Fractionated CO2 laser treatment - one time question
measure: Participant-perceived treatment satisfaction
timeFrame: Final study visit at 4-6 weeks after third Fractionated CO2 laser treatment - one time question
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Kaiser Permanente - Southern California Permanente Medical Group
state: California
city: Washington
country: United States
facility: MedStar Health
state: District of Columbia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Albuquerque
country: United States
facility: The University of New Mexico
state: New Mexico
city: New York
country: United States
facility: Columbia University
state: New York
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Allentown
country: United States
facility: The Institute for Female Pelvic Medicine & Reconstructive Surgery
state: Pennsylvania
city: Waukesha
country: United States
facility: Waukesha Memorial Hospital
state: Wisconsin
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.