The CO2RE® System for Vulvar Lichen Sclerosus
Completed · Not applicable
Conditions studied: Vulvar Lichen Sclerosus
In brief
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.
Key facts
- Study ID
- NCT04148651
- Run by
- Candela Corporation
- People needed
- 14
- Starts
- 2018-07-11
- Expected to finish
- 2020-12-17
- Last updated by the study team
- 2022-03-22
Who can join
Age: 18 and older, up to 80. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Presence of clinically atypical appearing nevi in the area to be treated;
- Unexplained vaginal bleeding;
- Active infection, specifically: urinary tract infection, vulvar or vaginal infection (candidiasis, genital herpes/herpes simplex virus, bacterial vaginosis, trichomonas);
- History of vulvar or any gynecological malignancy, as well as history of pelvic radiation therapy or stem cell transplant;
- Pelvic organ prolapse > stage 2;
- Pregnancy or planning pregnancy during the study;
- Systemic treatment with immuno-modulatory drugs.
- Use of vaginal dilators during study.
Where it is running
- Total Dermatology Care Center — Jacksonville, Florida, United States
- Center for Modern Aesthetic Medicine — Jacksonville, Florida, United States
- HERmd (formerly Somi Javaid M.D. & Associates) — Cincinnati, Ohio, United States
- Lumina Med Spa — South Burlington, Vermont, United States
Full record on ClinicalTrials.gov
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