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

Vulvar Lichen Sclerosus Clinical Trial

— VULVIE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04951206
• Other study ID #: MHRI IRB #STUDY00003851
• Status: Recruiting
• Phase: Phase 4
• Start date: March 1, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: July 2023
• Source: Medstar Health Research Institute
• Contact: Alexis Dieter, MD
• Phone: 202-877-6526
• Email: Alexis.a.dieter[@]medstar.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 184
• Est. completion date: June 30, 2025
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lichen Sclerosus et Atrophicus
• Vulvar Lichen Sclerosus

Intervention

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

Locations

Country	Name	City	State
United States	The University of New Mexico	Albuquerque	New Mexico
United States	The Institute for Female Pelvic Medicine & Reconstructive Surgery	Allentown	Pennsylvania
United States	Walter Reed National Military Medical Center	Bethesda	Maryland
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of Chicago	Chicago	Illinois
United States	Ohio State University	Columbus	Ohio
United States	Columbia University	New York	New York
United States	Kaiser Permanente - Southern California Permanente Medical Group	San Diego	California
United States	MedStar Health	Washington	District of Columbia
United States	Waukesha Memorial Hospital	Waukesha	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
Medstar Health Research Institute	Patty Brisben Foundation For Women's Sexual Health, Society of Gynecologic Surgeons

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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