RecruitingPhase 2NCT06075264

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

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)

Sponsor

Frantz Viral Therapeutics, LLC

Enrollment

27 participants

Start Date

Dec 6, 2023

Study Type

INTERVENTIONAL

Conditions

Vulvar Diseases HPV Infection High Grade Intraepithelial Neoplasia Pre-Cancerous Dysplasia Vulvar HSIL HPV Disease VIN, Usual Type VIN 2 of Usual Type VIN 3 of Usual Type Vin II Vin III VIN Grade 2 VIN Grade 3

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria12

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 Criteria11

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