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

ConditionsVulvar 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

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexFemale

Age18+

SponsorFrantz Viral Therapeutics, LLC

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

Artesunate ointment
Placebo ointment

Treatment groups

27 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Frantz Viral Therapeutics, LLC

Lead sponsor

The Cleveland Clinic

Collaborator

Source ClinicalTrials.gov