Phase II Study of Artesunate Ointment for the Treatment of Vulvar High Grade Squamous Intraepithelial Lesions (Vulvar HSIL, VIN2/3)
Start Date
12/6/2023
Completion Date
12/1/2027
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).
Detailed 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 Criteria
Age Range: 18 years to No maximum
Interventions
Artesunate ointment
Placebo ointment
Conditions
Locations
Florida Gynecologic Oncology
Fort Myers, Florida 33905
United States
Ascension St. Vincent
Indianapolis, Indiana 46260
United States
Cleveland Clinic Fairview Hospital
Cleveland, Ohio 44111
United States
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
Hillcrest Hospital
Mayfield Heights, Ohio 44124
United States