Status:
RECRUITING
Phase II Study of Artesunate Ointment for the Treatment of Vulvar High Grade Squamous Intraepithelial Lesions (Vulvar HSIL, VIN2/3)
Lead Sponsor:
Frantz Viral Therapeutics, LLC
Collaborating Sponsors:
The Cleveland Clinic
Conditions:
Vulvar Diseases
HPV Infection
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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).
Detailed Description
Eligible participants in this study are randomized 2:1 to receive either artesunate or placebo ointment for the treatment of vulvar HSIL. Both groups receive four 5-day cycles of topical ointment, at ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT06075264
Start Date
December 6 2023
End Date
December 1 2027
Last Update
August 14 2025
Active Locations (5)
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1
Florida Gynecologic Oncology
Fort Myers, Florida, United States, 33905
2
Ascension St. Vincent
Indianapolis, Indiana, United States, 46260
3
Cleveland Clinic Fairview Hospital
Cleveland, Ohio, United States, 44111
4
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195