A Phase II Double-blind, Placebo-controlled, Randomized Trial of Topical Artesunate Ointment for the Treatment of Patients With Vulvar High-grade Squamous Intraepithelial Lesions (Vulvar HSIL)
Frantz Viral Therapeutics, LLC
Summary
This is a phase II double-blind, placebo-controlled study of artesunate ointment for the treatment of HPV-associated vulvar HSIL (usual type vulvar intraepithelial neoplasia 2/3).
Description
Eligible participants in this study are randomized 2:1 to receive either artesunate or placebo ointment for the treatment of vulvar HSIL. Both groups receive four 5-day cycles of topical ointment, at weeks 0, 2, 4, and 6. Dosing visits may be done in person or as telehealth (ointment may be shipped directly to the patient). Participants are followed closely with vulvar examinations or colposcopies at weeks 8, 18, 6-months and 12-months.
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Adult women age ≥ 18 years * Capable of informed consent * Able to collaborate with planned follow-up (transportation, compliance history, etc) * Biopsy diagnosis of high-grade vulvar dysplasia (VIN2, VIN3, VIN2/3, HSIL), including both new and recurrent disease. A biopsy diagnosis of vulvar high-grade squamous intraepithelial lesion within the previous 3 months which was not excised or otherwise treated may be accepted for study entry. * Positive HPV test at study entry (any genotype). * Women of childbearing potential agree to use birth control during the dosing phase…
Interventions
- DrugArtesunate ointment
topical ointment, as a non-surgical treatment
- DrugPlacebo ointment
topical placebo ointment
Locations (5)
- Florida Gynecologic OncologyFort Myers, Florida
- Ascension St. VincentIndianapolis, Indiana
- Cleveland Clinic Fairview HospitalCleveland, Ohio
- Cleveland Clinic FoundationCleveland, Ohio
- Hillcrest HospitalMayfield Heights, Ohio