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NCT06075264PHASE2Recruiting

Phase II Study of Artesunate Ointment for the Treatment of Vulvar High Grade Squamous Intraepithelial Lesions (Vulvar HSIL, VIN2/3)

Frantz Viral Therapeutics, LLC

Start Date

12/6/2023

Completion Date

12/1/2027

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 weeks 0, 2, 4, and 6. Dosing visits may be done in person or as telehealth (ointment may be shipped directly to the patient). Participants are followed closely with vulvar examinations or colposcopies at weeks 8, 18, 6-months and 12-months.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Artesunate ointment

DRUG

Placebo ointment

Interested in This Trial?

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Conditions

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

Locations

Florida Gynecologic Oncology

Fort Myers, Florida 33905

United States

Ascension St. Vincent

Indianapolis, Indiana 46260

United States

Cleveland Clinic Fairview Hospital

Cleveland, Ohio 44111

United States

Cleveland Clinic Foundation

Cleveland, Ohio 44195

United States

Hillcrest Hospital

Mayfield Heights, Ohio 44124

United States