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

Sponsor

University of South Alabama (Other)

Overall Status

Recruiting

CT.gov ID

NCT05243563

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

2.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Vulvar Lichen Sclerosus	Device: MonaLisa Touch Drug: Topical steroid	Phase 2/Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Randomized, Unblinded Trial of Topical Steroids Plus CO2 Laser Compared to Steroids Alone in the Treatment of Vulvovaginal Lichen Sclerosus

Actual Study Start Date :

Apr 13, 2022

Anticipated Primary Completion Date :

Apr 13, 2023

Anticipated Study Completion Date :

Apr 13, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fractionated CO2 laser plus topical steroids 3 laser treatments at 6 week intervals for 6 months by a single trained operator	Device: MonaLisa Touch 3 laser treatments at 6 week intervals for 6 months by a single trained operator Other Names: SMARTXIDE2 Drug: Topical steroid self-applied topical steroid therapy using clobetasol propionate 0.05% Other Names: clobetasol propionate
Active Comparator: topical steroids alone self-applied topical steroid therapy using clobetasol propionate 0.05%	Drug: Topical steroid self-applied topical steroid therapy using clobetasol propionate 0.05% Other Names: clobetasol propionate

Arm

Intervention/Treatment

Experimental: Fractionated CO2 laser plus topical steroids

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

Device: MonaLisa Touch

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

Other Names:

SMARTXIDE2

Drug: Topical steroid

self-applied topical steroid therapy using clobetasol propionate 0.05%

Other Names:

clobetasol propionate

Active Comparator: topical steroids alone

self-applied topical steroid therapy using clobetasol propionate 0.05%

Drug: Topical steroid

self-applied topical steroid therapy using clobetasol propionate 0.05%

Other Names:

clobetasol propionate

Outcome Measures

Primary Outcome Measures

Change in Skindex-29 score [Completed by the subject at baseline and 6 months.]
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 [Scored by the provider at baseline and 6 months]
Providers will use this scale to objectively assess vulvar appearance. The tool uses is scored from 0 to 10 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 [Scored by the provider at 6 months]
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) [Administered at baseline and at 6 months by the provider.]
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) [Administered at baseline and at 6 months by the provider.]
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) [Administered at baseline and at 6 months by the provider.]
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) [Administered at baseline and at 6 months by the provider.]
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) [Administered at baseline and 6 months by an investigator to the subject]
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 [Administered by an investigator to the subject at 6 months.]
5 point scale of satisfaction: 0 = very unsatisfied, 1 = unsatisfied, 2 = neutral, 3 = satisfied, 4 = very satisfied
Change in symptom subjective visual analog score [Administered at baseline and 6 months by an investigator to the subject]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	USA Health Children's and Women's Hospital	Mobile	Alabama	United States	36604
2	USA Health Strata Patient Center	Mobile	Alabama	United States	36604

Sponsors and Collaborators

University of South Alabama

Investigators

Principal Investigator: Charles Hanes, MD, Adjunct Associate Professor of Obstetrics and Gynecology
Principal Investigator: Stephen Varner, MD, Associate Professor of Obstetrics and Gynecology