A Randomized, Unblinded Trial of Topical Steroids Plus CO2 Laser Compared to Steroids Alone in the Treatment of Vulvovaginal Lichen Sclerosus
Overview
- Phase
- Phase 2
- Intervention
- MonaLisa Touch
- Conditions
- Vulvar Lichen Sclerosus
- Sponsor
- University of South Alabama
- Enrollment
- 52
- Locations
- 2
- Primary Endpoint
- Change in Skindex-29 Score
- Status
- Terminated
- Last Updated
- 10 months ago
Overview
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.
Investigators
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
Arms & Interventions
Fractionated CO2 laser plus topical steroids
3 laser treatments at 6 week intervals for 6 months by a single trained operator
Intervention: MonaLisa Touch
Fractionated CO2 laser plus topical steroids
3 laser treatments at 6 week intervals for 6 months by a single trained operator
Intervention: Topical steroid
topical steroids alone
self-applied topical steroid therapy using clobetasol propionate 0.05%
Intervention: Topical steroid
Outcomes
Primary Outcomes
Change in Skindex-29 Score
Time Frame: 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 Outcomes
- Change in Objective Visual Analog Scale(Scored by the provider at baseline and 6 months)
- Change in Vulvovaginal Symptoms Questionnaire (VSQ) Score (Total Score)(Administered at baseline and at 6 months by the provider.)
- Change in Vulvovaginal Symptoms Questionnaire Score (Symptoms Component Only)(Administered at baseline and at 6 months by the provider.)
- Change in Vulvovaginal Symptoms Questionnaire Score (Emotion Component Only)(Administered at baseline and at 6 months by the provider.)
- Change in Vulvovaginal Symptoms Questionnaire Score (Life Impact Component Only)(Administered at baseline and at 6 months by the provider.)
- Change in Vulvovaginal Symptoms Questionnaire Score (Sexual Impact Component Only)(Administered at baseline and 6 months by an investigator to the subject)
- Change in Symptom Subjective Visual Analog Score(Administered at baseline and 6 months by an investigator to the subject)