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

• Status: Recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Frantz Viral Therapeutics, LLC
• Collaborator: The Cleveland Clinic
• Treatments: Artemisinin; Artemisinins; Artenimol; Artesunate

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 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