Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT04148651
Eligibility Criteria:
Inclusion Criteria:
1. Able to read, understand and sign informed consent for study participation;
2. Female subjects with age 18-80 years;
3. Biopsy demonstrates biopsy-proven lichen sclerosus and/or there are characteristic changes for vulvar lichen sclerosus on physical examination;
4. 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;
5. Topical corticosteroid treatment, if any, will be continued during the study period;
6. Exogenous hormone treatment, if any, will be continued during the study period (type and dose must stay consistent throughout the study);
7. One or more of the following symptoms: itch; pain unrelated to intercourse; pain, skin tearing or bleeding with intercourse; changes/decrease in sexual function;
8. No breaks, tears or lesions, malodorous discharge or strawberry cervix present on gynecological exam.
Exclusion Criteria:
1. Presence of clinically atypical appearing nevi in the area to be treated;
2. Unexplained vaginal bleeding;
3. Active infection, specifically: urinary tract infection, vulvar or vaginal infection (candidiasis, genital herpes/herpes simplex virus, bacterial vaginosis, trichomonas);
4. History of vulvar or any gynecological malignancy, as well as history of pelvic radiation therapy or stem cell transplant;
5. Pelvic organ prolapse \> stage 2;
6. Pregnancy or planning pregnancy during the study;
7. Systemic treatment with immuno-modulatory drugs.
8. Use of vaginal dilators during study.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04148651
Study Brief:
Protocol Section:
NCT04148651