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Does Steroid Plus CO2 Laser Improve Lichen Sclerosus Symptoms Compared to Steroids Alone?

Primary Purpose

Vulvar Lichen Sclerosus

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MonaLisa Touch
Topical steroid
Sponsored by
University of South Alabama
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vulvar Lichen Sclerosus focused on measuring MonaLisa Touch, fractionated laser, SMARTXIDE2

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • women with biopsy proven lichen sclerosus and significant symptoms based on Skindex-29 scores >21

Exclusion Criteria:

  • prior vaginal mesh or pelvic radiation
  • active genital infection
  • Current or past gynecologic malignancy

Sites / Locations

  • USA Health Children's and Women's HospitalRecruiting
  • USA Health Strata Patient CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fractionated CO2 laser plus topical steroids

topical steroids alone

Arm Description

3 laser treatments at 6 week intervals for 6 months by a single trained operator

self-applied topical steroid therapy using clobetasol propionate 0.05%

Outcomes

Primary Outcome Measures

Change in Skindex-29 score
The Skindex-29 is a validated tool to assess impact of a chronic skin condition on a person's quality of life. It has been previously used to describe the effects of a treatment and to compare treatments. Values range from 1 (Never) to 5 (All the time). The higher the score, the worse the outcome.

Secondary Outcome Measures

Change in Objective Visual Analog Scale
Providers will use this scale to objectively assess vulvar appearance. The tool uses is scored from 0 to 3 (0= absent, 1= mild, 2= moderate, 3= severe) on nine different features of lichen sclerosus (white plaques or hypopigementation, cigarette paper or thin skin, introital narrowing, perianal involvment, loss of labia minora, fusion of labia minora, vulvar fissures, and vulvar erosion). A higher score indicates a higher severity. A higher change in score indicates greater improvement.
Global Subjective Visual Analog Scale
Providers will use this scale to subjectively assess improvement in vulvar appearance. The provider will grade the improvement from baseline on a 6 point scale, with 0 being "much worse" and 5 being "much better".
Change in Vulvovaginal Symptoms Questionnaire (VSQ) score (Total Score)
This 21 item questionnaire assess four aspects impacting quality of life for patients with vulvovaginal skin diseases: symptoms, emotions, life impact and sexual impact. A higher score corresponds to more bothersome symptoms. The values are 0 (No) or 1 (Yes). The higher the score, the worse the outcome. A higher change in these scores indicates more improvement.
Change in Vulvovaginal Symptoms Questionnaire score (Symptoms Component only)
A subset of the total score on the VSQ, looking at symptoms only. A higher score corresponds to more bothersome symptoms. The values are 0 (No) or 1 (Yes). The higher the score, the worse the outcome. A higher change in these scores indicates more improvement.
Change in Vulvovaginal Symptoms Questionnaire score (Emotion Component only)
A subset of the total score on the VSQ, looking at scores for emotions questions only. A higher score corresponds to more emotional impact. The values are 0 (No) or 1 (Yes). The higher the score, the worse the outcome. A higher change in these scores indicates more improvement.
Change in Vulvovaginal Symptoms Questionnaire score (Life Impact Component only)
A subset of the total score on the VSQ, looking at scores for life impact questions only. A higher score corresponds to more impact. The values are 0 (No) or 1 (Yes). The higher the score, the worse the outcome. A higher change in these scores indicates more improvement.
Change in Vulvovaginal Symptoms Questionnaire score (Sexual Impact Component only)
A subset of the total score on the VSQ, looking at scores for sexual impact questions only. A higher score corresponds to more impact. The values are 0 (No) or 1 (Yes). The higher the score, the worse the outcome. A higher change in these scores indicates more improvement.
Patient reported satisfaction with treatment
5 point scale of satisfaction: 0 = very unsatisfied, 1 = unsatisfied, 2 = neutral, 3 = satisfied, 4 = very satisfied
Change in symptom subjective visual analog score
This measures the subjects perception of 9 key vulvovaginal symptoms: itching, burning, irritation, pain with intercourse, tearing of vulvar skin, painful urination and painful defecation. Each is scored from 0 -10, with 10 indicating the most symptoms.

Full Information

First Posted
February 7, 2022
Last Updated
September 16, 2022
Sponsor
University of South Alabama
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1. Study Identification

Unique Protocol Identification Number
NCT05243563
Brief Title
Does Steroid Plus CO2 Laser Improve Lichen Sclerosus Symptoms Compared to Steroids Alone?
Official Title
A Randomized, Unblinded Trial of Topical Steroids Plus CO2 Laser Compared to Steroids Alone in the Treatment of Vulvovaginal Lichen Sclerosus
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 13, 2022 (Actual)
Primary Completion Date
April 13, 2023 (Anticipated)
Study Completion Date
April 13, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Alabama

4. Oversight

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

5. Study Description

Brief Summary
This study will compare the effects of fractionated CO2 laser plus topical steroids versus topical steroids alone in treatment of lichen sclerosus.
Detailed Description
Vulvar lichen sclerosus is a common benign skin condition which causes pain and itching. Topical steroids have been the main treatment. A recent study showed that fractionated CO2 laser treatment is non inferior and actually may improve subjective symptoms compared to topical steroids with no serious safety or adverse events. Because steroids reduce risk of vulvar cancer in patients with lichen sclerosus, the investigators hypothesize that steroids in addition to the fractionated laser will provide greater symptom relief while still allowing patient the benefits of steroid treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvar Lichen Sclerosus
Keywords
MonaLisa Touch, fractionated laser, SMARTXIDE2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fractionated CO2 laser plus topical steroids
Arm Type
Experimental
Arm Description
3 laser treatments at 6 week intervals for 6 months by a single trained operator
Arm Title
topical steroids alone
Arm Type
Active Comparator
Arm Description
self-applied topical steroid therapy using clobetasol propionate 0.05%
Intervention Type
Device
Intervention Name(s)
MonaLisa Touch
Other Intervention Name(s)
SMARTXIDE2
Intervention Description
3 laser treatments at 6 week intervals for 6 months by a single trained operator
Intervention Type
Drug
Intervention Name(s)
Topical steroid
Other Intervention Name(s)
clobetasol propionate
Intervention Description
self-applied topical steroid therapy using clobetasol propionate 0.05%
Primary Outcome Measure Information:
Title
Change in Skindex-29 score
Description
The Skindex-29 is a validated tool to assess impact of a chronic skin condition on a person's quality of life. It has been previously used to describe the effects of a treatment and to compare treatments. Values range from 1 (Never) to 5 (All the time). The higher the score, the worse the outcome.
Time Frame
Completed by the subject at baseline and 6 months.
Secondary Outcome Measure Information:
Title
Change in Objective Visual Analog Scale
Description
Providers will use this scale to objectively assess vulvar appearance. The tool uses is scored from 0 to 3 (0= absent, 1= mild, 2= moderate, 3= severe) on nine different features of lichen sclerosus (white plaques or hypopigementation, cigarette paper or thin skin, introital narrowing, perianal involvment, loss of labia minora, fusion of labia minora, vulvar fissures, and vulvar erosion). A higher score indicates a higher severity. A higher change in score indicates greater improvement.
Time Frame
Scored by the provider at baseline and 6 months
Title
Global Subjective Visual Analog Scale
Description
Providers will use this scale to subjectively assess improvement in vulvar appearance. The provider will grade the improvement from baseline on a 6 point scale, with 0 being "much worse" and 5 being "much better".
Time Frame
Scored by the provider at 6 months
Title
Change in Vulvovaginal Symptoms Questionnaire (VSQ) score (Total Score)
Description
This 21 item questionnaire assess four aspects impacting quality of life for patients with vulvovaginal skin diseases: symptoms, emotions, life impact and sexual impact. A higher score corresponds to more bothersome symptoms. The values are 0 (No) or 1 (Yes). The higher the score, the worse the outcome. A higher change in these scores indicates more improvement.
Time Frame
Administered at baseline and at 6 months by the provider.
Title
Change in Vulvovaginal Symptoms Questionnaire score (Symptoms Component only)
Description
A subset of the total score on the VSQ, looking at symptoms only. A higher score corresponds to more bothersome symptoms. The values are 0 (No) or 1 (Yes). The higher the score, the worse the outcome. A higher change in these scores indicates more improvement.
Time Frame
Administered at baseline and at 6 months by the provider.
Title
Change in Vulvovaginal Symptoms Questionnaire score (Emotion Component only)
Description
A subset of the total score on the VSQ, looking at scores for emotions questions only. A higher score corresponds to more emotional impact. The values are 0 (No) or 1 (Yes). The higher the score, the worse the outcome. A higher change in these scores indicates more improvement.
Time Frame
Administered at baseline and at 6 months by the provider.
Title
Change in Vulvovaginal Symptoms Questionnaire score (Life Impact Component only)
Description
A subset of the total score on the VSQ, looking at scores for life impact questions only. A higher score corresponds to more impact. The values are 0 (No) or 1 (Yes). The higher the score, the worse the outcome. A higher change in these scores indicates more improvement.
Time Frame
Administered at baseline and at 6 months by the provider.
Title
Change in Vulvovaginal Symptoms Questionnaire score (Sexual Impact Component only)
Description
A subset of the total score on the VSQ, looking at scores for sexual impact questions only. A higher score corresponds to more impact. The values are 0 (No) or 1 (Yes). The higher the score, the worse the outcome. A higher change in these scores indicates more improvement.
Time Frame
Administered at baseline and 6 months by an investigator to the subject
Title
Patient reported satisfaction with treatment
Description
5 point scale of satisfaction: 0 = very unsatisfied, 1 = unsatisfied, 2 = neutral, 3 = satisfied, 4 = very satisfied
Time Frame
Administered by an investigator to the subject at 6 months.
Title
Change in symptom subjective visual analog score
Description
This measures the subjects perception of 9 key vulvovaginal symptoms: itching, burning, irritation, pain with intercourse, tearing of vulvar skin, painful urination and painful defecation. Each is scored from 0 -10, with 10 indicating the most symptoms.
Time Frame
Administered at baseline and 6 months by an investigator to the subject

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: women with biopsy proven lichen sclerosus and significant symptoms based on Skindex-29 scores >21 Exclusion Criteria: prior vaginal mesh or pelvic radiation active genital infection Current or past gynecologic malignancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catera Duhon, RN, BSN
Phone
251-415-1598
Email
cduhon@health.southalabama.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Hanes, MD
Organizational Affiliation
Adjunct Associate Professor of Obstetrics and Gynecology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephen Varner, MD
Organizational Affiliation
Associate Professor of Obstetrics and Gynecology
Official's Role
Principal Investigator
Facility Information:
Facility Name
USA Health Children's and Women's Hospital
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catera Duhon, RN, BSN
Phone
251-415-1598
Email
cduhon@health.southalabama.edu
First Name & Middle Initial & Last Name & Degree
Charles Hanes, MD
Facility Name
USA Health Strata Patient Center
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catera Duhon, RN, BSN
Phone
251-415-1598
Email
cduhon@health.southalabama.edu

12. IPD Sharing Statement

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Does Steroid Plus CO2 Laser Improve Lichen Sclerosus Symptoms Compared to Steroids Alone?

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