Clinical trial NCT05243563: 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
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Vulvar Lichen Sclerosus
Keywords: MonaLisa Touch
fractionated laser
SMARTXIDE2
Lead sponsor: University of South Alabama
Sponsor class: OTHER
First posted: 2022-02-17
Enrollment: 11
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Skindex-29 Score
timeFrame: Completed by the subject at baseline and 6 months.
Secondary outcomes:
measure: Change in Objective Visual Analog Scale
timeFrame: Scored by the provider at baseline and 6 months
measure: Change in Vulvovaginal Symptoms Questionnaire (VSQ) Score (Total Score)
timeFrame: Administered at baseline and at 6 months by the provider.
measure: Change in Vulvovaginal Symptoms Questionnaire Score (Symptoms Component Only)
timeFrame: Administered at baseline and at 6 months by the provider.
measure: Change in Vulvovaginal Symptoms Questionnaire Score (Emotion Component Only)
timeFrame: Administered at baseline and at 6 months by the provider.
measure: Change in Vulvovaginal Symptoms Questionnaire Score (Life Impact Component Only)
timeFrame: Administered at baseline and at 6 months by the provider.
measure: Change in Vulvovaginal Symptoms Questionnaire Score (Sexual Impact Component Only)
timeFrame: Administered at baseline and 6 months by an investigator to the subject
measure: Change in Symptom Subjective Visual Analog Score
timeFrame: Administered at baseline and 6 months by an investigator to the subject
Other outcomes:
Locations:
city: Mobile
country: United States
facility: USA Health Children's and Women's Hospital
state: Alabama
city: Mobile
country: United States
facility: USA Health Strata Patient Center
state: Alabama
Study officials:
affiliation: Adjunct Associate Professor of Obstetrics and Gynecology
name: Charles Hanes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor of Obstetrics and Gynecology
name: Stephen Varner, MD
role: PRINCIPAL_INVESTIGATOR
References: