Clinical Trials in the USA / NCT06075264
Recruiting
Phase 2
Phase II Study of Artesunate Ointment for the Treatment of Vulvar High Grade Squamous Intraepithelial Lesions (Vulvar HSIL, VIN2/3)
NCT06075264 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Vulvar DiseasesHPV InfectionVulvar HSILPre-Cancerous DysplasiaHPV DiseaseVIN, Usual TypeVIN 2 of Usual TypeVIN 3 of Usual TypeVin IIVin IIIVIN Grade 2VIN Grade 3High Grade Intraepithelial Neoplasia
Investigational drug(s) / intervention(s)
Artesunate ointment →Placebo ointment
Artesunate ointment: topical ointment, as a non-surgical treatment
Placebo ointment: topical placebo ointment
Study 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).
Eligibility
Inclusion Criteria:
* 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 Criteria:
* 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
Primary outcome measure(s)
- Number of participants with complete histologic response — 18 weeks
Number of participants who have complete histologic response following topical artesunate ointment
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| Florida Gynecologic Oncology | Fort Myers | Florida | Recruiting |
| Ascension St. Vincent | Indianapolis | Indiana | Recruiting |
| Cleveland Clinic Fairview Hospital | Cleveland | Ohio | Recruiting |
| Cleveland Clinic Foundation | Cleveland | Ohio | Recruiting |
| Hillcrest Hospital | Mayfield Heights | Ohio | Recruiting |
More Frantz Viral Therapeutics, LLC trials in the USA
Artesunate Suppositories for the Treatment of HIV-negative Patients With Intra-anal HSIL
Active, not recruiting
Other trials for the same condition
SELF-CERV Pivotal Study: SELF-Collection for CERVical Cancer Screening
Active, not recruiting
Artesunate Suppositories for the Treatment of HIV-negative Patients With Intra-anal HSIL
Active, not recruiting
Artesunate Vaginal Inserts for the Treatment of Cervical Intraepithelial Neoplasia (CIN2/3)
Recruiting
Early Phase Clinical Trial About Therapeutic Biological Product Mix for Treating HPV
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06075264 on ClinicalTrials.gov ↗ ← All trials in the USA