Actively Recruiting
Phase II Study of Artesunate Ointment for the Treatment of Vulvar High Grade Squamous Intraepithelial Lesions (Vulvar HSIL, VIN2/3)
Led by Frantz Viral Therapeutics, LLC · Updated on 2025-08-14
27
Participants Needed
5
Research Sites
208 weeks
Total Duration
On this page
Sponsors
F
Frantz Viral Therapeutics, LLC
Lead Sponsor
T
The Cleveland Clinic
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Phase II Study of Artesunate Ointment for the Treatment of Vulvar High Grade Squamous Intraepithelial Lesions (Vulvar HSIL, VIN2/3)
Who Can Participate
Eligibility Criteria
You may qualify if you...
-
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).
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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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
Florida Gynecologic Oncology
Fort Myers, Florida, United States, 33905
Actively Recruiting
2
Ascension St. Vincent
Indianapolis, Indiana, United States, 46260
Actively Recruiting
3
Cleveland Clinic Fairview Hospital
Cleveland, Ohio, United States, 44111
Actively Recruiting
4
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
5
Hillcrest Hospital
Mayfield Heights, Ohio, United States, 44124
Actively Recruiting
Research Team
M
Mihaela Plesa
CONTACT
A
Ahmad Bayat, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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