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)
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).
• 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