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

Launched by FRANTZ VIRAL THERAPEUTICS, LLC · Oct 4, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called artesunate ointment for women with a condition known as vulvar high-grade squamous intraepithelial lesions (HSIL), which can be a pre-cancerous condition often associated with the human papillomavirus (HPV). The study aims to find out if this ointment can effectively treat these lesions. Women who are at least 18 years old and have been diagnosed with vulvar HSIL through a biopsy in the last three months may be eligible to participate. They should also have a positive HPV test and agree to follow the study’s guidelines.

Participants in this study can expect to receive either the artesunate ointment or a placebo (a treatment that has no active ingredients) for eight weeks. They will need to return for follow-up appointments, including a procedure after 18 weeks to check the progress of their condition. It's important to note that pregnant or nursing women, as well as those with certain other health conditions, will not be able to participate. This trial is currently recruiting, so interested women should speak with their healthcare provider for more information.

Gender

FEMALE

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 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