The CO2RE® System for Vulvar Lichen Sclerosus (NCT04148651) | Clinical Trial Compass
CompletedNot Applicable
The CO2RE® System for Vulvar Lichen Sclerosus
United States14 participantsStarted 2018-07-11
Plain-language summary
Subjects with vulvar lichen sclerosus (VLS) will undergo fractional carbon dioxide (CO2) laser treatment to the vulvar area. Subjects will be evaluated for changes in clinical signs and architectural changes associated with VLS at designated follow-ups to 1-year post treatment series.
Who can participate
Age range18 Years – 80 Years
SexFEMALE
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Inclusion criteria
✓. Able to read, understand and sign informed consent for study participation;
✓. Female subjects with age 18-80 years;
✓. Biopsy demonstrates biopsy-proven lichen sclerosus and/or there are characteristic changes for vulvar lichen sclerosus on physical examination;
✓. Treatment of LS has been recalcitrant to mid to high-potent topical corticosteroid treatment or subject refuses topical corticosteroid treatment. Recalcitrance to therapy is defined as no response to topical corticosteroids of an adequate potency (i.e. clobetasol propionate 0.05% ointment or other steroids) and a sufficient duration (12 weeks of use) or lack of symptomatic control of the disease with a maintenance therapy;
✓. Topical corticosteroid treatment, if any, will be continued during the study period;
✓. Exogenous hormone treatment, if any, will be continued during the study period (type and dose must stay consistent throughout the study);
✓. One or more of the following symptoms: itch; pain unrelated to intercourse; pain, skin tearing or bleeding with intercourse; changes/decrease in sexual function;
✓. No breaks, tears or lesions, malodorous discharge or strawberry cervix present on gynecological exam.
Exclusion criteria
✕. Presence of clinically atypical appearing nevi in the area to be treated;
✕. Unexplained vaginal bleeding;
What they're measuring
1
Average Scores for VLS Clinical Signs Present At Baseline, 3, 6 and 12 Months After the Last Treatment as Assessed by the Investigators
Timeframe: At Baseline, 3, 6 and 12 months after the final treatment
2
Average Scores for VLS Architectural Changes Present At Baseline and at 3, 6 and 12 Months After the Last Treatment as Assessed by the Investigators
Timeframe: Baseline, 3 , 6 and 12 months after the final treatment