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

NCT04951206 | Completed Phase 4 FDA Drug

• 1 other identifier: MHRI IRB #STUDY00003851
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 10

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.

Conditions

Vulvar Lichen Sclerosus

Keywords

Clobetasol propionate; Fractionated CO2-laser

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Treatment response - vulvovaginal symptoms

  About 5 months (baseline to final visit)

• Treatment response - sexual function

  About 5 months (baseline to final visit)

• Treatment response - genital self image

  About 5 months (baseline to final visit)

• Treatment response - lower urinary tract function

  About 5 months (baseline to final visit)

• Participant-perceived improvement

  Final study visit at 4-6 weeks after third Fractionated CO2 laser treatment - one time question

Study Arms (2)

Clobetasol Group

ACTIVE COMPARATOR

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).

Device: Fractionated CO2-laser; Drug: Clobetasol Propionate 0.05% Ointment

Placebo Group

PLACEBO COMPARATOR

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).

Device: Fractionated CO2-laser

Interventions

Fractionated CO2-laser DEVICE

All women will be undergoing FxCO2-laser therapy as this treatment is a criterion for enrollment.

Clobetasol Group; Placebo Group

Clobetasol Propionate 0.05% Ointment DRUG

Clobetasol propionate 0.05% ointment obtained from a commercial manufacturer

Also known as: Clobetasol

Clobetasol Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This study is investigating treatment of vulvar lichen sclerosus and thus participants will be limited to women with vulvar lichen sclerosus
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medstar Health Research Institute: lead
• Patty Brisben Foundation For Women's Sexual Health: collaborator
• Society of Gynecologic Surgeons: collaborator

Study Sites (10)

Kaiser Permanente - Southern California Permanente Medical Group

San Diego, California, 92110, United States

Location

MedStar Health

Washington D.C., District of Columbia, 20036, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20814, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

The University of New Mexico

Albuquerque, New Mexico, 87106, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

The Institute for Female Pelvic Medicine & Reconstructive Surgery

Allentown, Pennsylvania, 18103, United States

Location

Waukesha Memorial Hospital

Waukesha, Wisconsin, 53188, United States

Location

Related Publications (7)

• 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.

  PMID: 22284137 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.

  PMID: 10782451 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.

  PMID: 21044269 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.

  PMID: 20233278 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.

  PMID: 31135654 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.

  PMID: 31364922 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.

  PMID: 23481118 BACKGROUND

MeSH Terms

Conditions

Vulvar Lichen Sclerosus

Interventions

Clobetasol; Ointments

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Betamethasone; Steroids, Fluorinated; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: July 6, 2021
• Study Start: March 1, 2022
• Primary Completion: April 25, 2025
• Study Completion: April 25, 2025
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)