Phase II Study of Artesunate Ointment for the Treatment of Vulvar High Grade Squamous Intraepithelial Lesions (Vulvar HSIL, VIN2/3)
NCT ID: NCT06075264
Last Updated: 2025-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
27 participants
INTERVENTIONAL
2023-12-06
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Artesunate ointment
Artesunate formulated as topical ointment, 40% Four 5-day cycles of artesunate ointment every 2 weeks
Artesunate ointment
topical ointment, as a non-surgical treatment
Placebo ointment
Placebo ointment Four 5-day cycles of placebo ointment every 2 weeks
Placebo ointment
topical placebo ointment
Interventions
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Artesunate ointment
topical ointment, as a non-surgical treatment
Placebo ointment
topical placebo ointment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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The Cleveland Clinic
OTHER
Frantz Viral Therapeutics, LLC
INDUSTRY
Responsible Party
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Locations
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Florida Gynecologic Oncology
Fort Myers, Florida, United States
Ascension St. Vincent
Indianapolis, Indiana, United States
Cleveland Clinic Fairview Hospital
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Hillcrest Hospital
Mayfield Heights, Ohio, United States
Countries
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Central Contacts
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Ahmad Bayat, MD
Role: CONTACT
Facility Contacts
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Other Identifiers
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23-889
Identifier Type: OTHER
Identifier Source: secondary_id
ART-VIN IIB
Identifier Type: -
Identifier Source: org_study_id
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