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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Vulvar Diseases, HPV Infection, Vulvar HSIL, Pre-Cancerous Dysplasia, 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, High Grade Intraepithelial Neoplasia

In brief

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).

Key facts

Study ID

NCT06075264

Run by

Frantz Viral Therapeutics, LLC

People needed

27

Starts

2023-12-06

Expected to finish

2027-12-01

Last updated by the study team

2025-08-14

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Florida Gynecologic Oncology — Fort Myers, Florida, United States (enrolling)
• Ascension St. Vincent — Indianapolis, Indiana, United States (enrolling)
• Cleveland Clinic Fairview Hospital — Cleveland, Ohio, United States (enrolling)
• Cleveland Clinic Foundation — Cleveland, Ohio, United States (enrolling)
• Hillcrest Hospital — Mayfield Heights, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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