Phase II Study of Artesunate Ointment for the Treatment of Vulvar High Grade Squamous Intraepithelial Lesions (Vulvar HSIL, VIN2/3) (ART-VIN IIB)

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 (through week 8). Laboratory values at Screening of: Serum alanine transaminase (SGPT/ALT) < 5 x upper limit of normal (ULN) Serum aspartate transaminase (SGOT/AST) < 5 x ULN Serum Bilirubin (total) < 2.5 x ULN Serum Creatinine ≤ 1.5 x ULN Weight ≥ 50kg Exclusion Criteria: Pregnant and nursing women Concurrent anal, vulvar, or cervical cancer HIV-positive participants with a CD4 count < 200 Participants infected with HIV-1 if not on a stable, suppressive antiretroviral therapy (ART) regimen. Unwillingness to undergo an excisional procedure at week 18 to either remove HSIL lesions, or to document histologic regression at a site where HSIL was present at study entry. Currently receiving systemic chemotherapy or radiation therapy for another cancer. Concomitant use of Efavirenz for HIV antiretroviral treatment Concomitant use of strong UGT inhibitors Concomitant use of imiquimod, cidofovir, or 5-fluorouracil (5-FU) for the duration of the study Concurrent dermatological conditions affecting the vulva (e.g., herpetic lesion, Crohn's disease, hidradenitis suppurativa) or vulvar dermatoses (e.g., lichen sclerosis or planus, atopic dermatitis, genital atrophy). Concurrent treatment with systemic corticosteroids