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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
Phase
Phase 2
Started
2023-12-06
Last updated
2025-08-14

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

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

FacilityCityRegionStatus
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
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