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

Study Overview
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Brief Summary
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This study will compare the effects of fractionated CO2 laser plus topical steroids versus topical steroids alone in treatment of lichen sclerosus.

Detailed Description
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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.

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

Conditions
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Vulvar Lichen Sclerosus

Intervention / Treatment
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* Device: MonaLisa Touch
* Drug: Topical steroid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Completed by the subject at baseline and 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Scored by the provider at baseline and 6 months | 
| 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. | Scored by the provider at 6 months | 
| 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. | Administered at baseline and at 6 months by the provider. | 
| 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. | Administered at baseline and at 6 months by the provider. | 
| 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. | Administered at baseline and at 6 months by the provider. | 
| 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. | Administered at baseline and at 6 months by the provider. | 
| 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. | Administered at baseline and 6 months by an investigator to the subject | 
| Patient reported satisfaction with treatment | 5 point scale of satisfaction: 0 = very unsatisfied, 1 = unsatisfied, 2 = neutral, 3 = satisfied, 4 = very satisfied | Administered by an investigator to the subject at 6 months. | 
| 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. | Administered at baseline and 6 months by an investigator to the subject | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MonaLisa Touch, fractionated laser, SMARTXIDE2