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:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT04134494
Eligibility Criteria:
We are currently recruiting Massachusetts residents only due to COVID-19.
Inclusion Criteria:
* Female
* Aged 18 years old or older
* Biopsy-proven active vulvar lichen sclerosus
* Characteristic changes of vulvar lichen sclerosus on gynecological exam
* Self-reported indication of one or more of the following symptoms of lichen sclerosus
* Dryness
* Itching
* Burning
* Bleeding
* Blistering
* Soreness
* Easily bruises
* Easily tears
* Ulcerated lesions
* Painful intercourse
* Ability to complete questionnaires in English
* Written, informed consent
* Willing and able to logistically follow schedule of treatments and follow-up visits
Exclusion Criteria:
* Receiving systemic immunosuppressant's (e.g. corticosteroids) within 4 weeks of enrollment
* Use of topical vulvar steroid-containing creams at the affected area within 4 weeks of enrollment
* Immunocompromised (e.g. lymphoma, AIDS, Wiskott-Aldrich syndrome)
* History of uncontrolled malignant disease
* Additional genital skin disease
* Known allergy or intolerance to topical anesthesia
* Known history of connective tissue disease
* Known propensity for keloid formations
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04134494
Study Brief:
Protocol Section:
NCT04134494