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

• 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