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

Primary Purpose

Vulvar Lichen Sclerosus

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Fractionated CO2-laser
Clobetasol Propionate 0.05% Ointment
Sponsored by
Medstar Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vulvar Lichen Sclerosus focused on measuring Clobetasol propionate, Fractionated CO2-laser

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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 (for women of childbearing potential, pregnancy testing will be conducted at screening, before each FxCO2 laser treatment and at the end of the study)
  • 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.

Sites / Locations

  • Kaiser Permanente - Southern California Permanente Medical GroupRecruiting
  • MedStar HealthRecruiting
  • University of Chicago
  • Walter Reed National Military Medical CenterRecruiting
  • Massachusetts General Hospital
  • The University of New MexicoRecruiting
  • Columbia UniversityRecruiting
  • Ohio State University
  • The Institute for Female Pelvic Medicine & Reconstructive SurgeryRecruiting
  • Waukesha Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Clobetasol Group

Placebo Group

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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).
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."
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".

Full Information

First Posted
June 22, 2021
Last Updated
August 21, 2023
Sponsor
Medstar Health Research Institute
Collaborators
Patty Brisben Foundation For Women's Sexual Health, Society of Gynecologic Surgeons
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1. Study Identification

Unique Protocol Identification Number
NCT04951206
Brief Title
Fractionated CO2 Laser With and Without Clobetasol for Treatment of Vulvar Lichen Sclerosus
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
July 30, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medstar Health Research Institute
Collaborators
Patty Brisben Foundation For Women's Sexual Health, Society of Gynecologic Surgeons

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvar Lichen Sclerosus
Keywords
Clobetasol propionate, Fractionated CO2-laser

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
184 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Clobetasol Group
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Fractionated CO2-laser
Intervention Description
All women will be undergoing FxCO2-laser therapy as this treatment is a criterion for enrollment.
Intervention Type
Drug
Intervention Name(s)
Clobetasol Propionate 0.05% Ointment
Other Intervention Name(s)
Clobetasol
Intervention Description
Clobetasol propionate 0.05% ointment obtained from a commercial manufacturer
Primary Outcome Measure Information:
Title
Treatment success
Description
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.
Time Frame
About 5 months (baseline to final visit)
Secondary Outcome Measure Information:
Title
Treatment response - vulvovaginal symptoms
Description
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.
Time Frame
About 5 months (baseline to final visit)
Title
Treatment response - sexual function
Description
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.
Time Frame
About 5 months (baseline to final visit)
Title
Treatment response - genital self image
Description
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.
Time Frame
About 5 months (baseline to final visit)
Title
Treatment response - lower urinary tract function
Description
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).
Time Frame
About 5 months (baseline to final visit)
Title
Participant-perceived improvement
Description
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."
Time Frame
Final study visit at 4-6 weeks after third Fractionated CO2 laser treatment - one time question
Title
Participant-perceived treatment satisfaction
Description
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".
Time Frame
Final study visit at 4-6 weeks after third Fractionated CO2 laser treatment - one time question

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
This study is investigating treatment of vulvar lichen sclerosus and thus participants will be limited to women with vulvar lichen sclerosus
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexis Dieter, MD
Phone
202-877-6526
Email
Alexis.a.dieter@medstar.net
First Name & Middle Initial & Last Name or Official Title & Degree
Melissa Gonzales
Email
melissa.k.gonzales@medstar.net
Facility Information:
Facility Name
Kaiser Permanente - Southern California Permanente Medical Group
City
San Diego
State/Province
California
ZIP/Postal Code
92110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kimberly Ferrante
Facility Name
MedStar Health
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20036
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexis Dieter, MD
First Name & Middle Initial & Last Name & Degree
Cheryl Iglesia
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margaret Mueller
First Name & Middle Initial & Last Name & Degree
Kimberly Kenton
Facility Name
Walter Reed National Military Medical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Vaccarro
First Name & Middle Initial & Last Name & Degree
Meagan Simpson
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Von Bargen
Facility Name
The University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kate Meriwether
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ladin Yurteri-Kaplan
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Hickman
First Name & Middle Initial & Last Name & Degree
Silpa Nekkanti
Facility Name
The Institute for Female Pelvic Medicine & Reconstructive Surgery
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Akira Gillingham
Facility Name
Waukesha Memorial Hospital
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarit Aschkenazi-Steinberg

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22284137
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.
Results Reference
background
PubMed Identifier
10782451
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.
Results Reference
background
PubMed Identifier
21044269
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.
Results Reference
background
PubMed Identifier
20233278
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.
Results Reference
background
PubMed Identifier
31135654
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.
Results Reference
background
PubMed Identifier
31364922
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.
Results Reference
background
PubMed Identifier
23481118
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.
Results Reference
background

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

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