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

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.

Timeline

Start

2022-03-01

Primary completion

2025-04-25

Completion

2025-04-25

Publications

• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.

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