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

Locations

Florida Gynecologic Oncology33905, Fort MyersFlorida, United States

Ascension St. Vincent46260, IndianapolisIndiana, United States

Cleveland Clinic Fairview Hospital44111, ClevelandOhio, United States

Cleveland Clinic Foundation44195, ClevelandOhio, United States

Sponsors and collaborators

Frantz Viral Therapeutics, LLC

Lead sponsor

The Cleveland Clinic

Collaborator

Source ClinicalTrials.gov