NCT06075264 Phase II Study of Artesunate Ointment for the Treatment of Vulvar High Grade Squamous Intraepithelial Lesions (Vulvar HSIL, VIN2/3)
| NCT ID | NCT06075264 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Frantz Viral Therapeutics, LLC |
| Condition | Vulvar Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 27 participants |
| Start Date | 2023-12-06 |
| Primary Completion | 2026-12 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief 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).
Eligibility Criteria
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 CD