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Phase II Artesunate Ointment for Vulvar HSIL

This study is testing an artesunate ointment to see if it can treat high-grade squamous intraepithelial lesions (HSIL) on the vulva, which are pre-cancerous changes often linked to HPV. You might be able to join if you are an adult woman (18 or older) with a biopsy-confirmed diagnosis of vulvar HSIL (also called VIN2/3). The study is looking to see how many participants have a complete response to the treatment, meaning the lesions are gone, after 18 weeks. The current status of this study is unclear, and it plans to enroll 27 participants.

Study design
This is a Phase II, double-blind, placebo-controlled study where participants are randomly assigned to receive either artesunate ointment or a placebo ointment. About 27 women are expected to participate.
What's involved
You would apply an ointment in four 5-day cycles over six weeks. You will also have vulvar exams or colposcopies at weeks 8, 18, 6 months, and 12 months.
Compensation
Not stated in the trial record.
Follow-up
Participants are followed for 12 months after treatment, with examinations at weeks 8, 18, 6 months, and 12 months.

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NCT06075264

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Frantz Viral Therapeutics, LLC
~27 participants
Updated 2025-08-14 on ClinicalTrials.gov
What's tested:Artesunate ointmentPlacebo ointment

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with complete histologic response
Measured over 18 weeks

Conditions

Vulvar Diseases
HPV Infection
Vulvar HSIL
Pre-Cancerous Dysplasia
HPV Disease
VIN, Usual Type
VIN 2 of Usual Type
VIN 3 of Usual Type
Vin II
Vin III
VIN Grade 2
VIN Grade 3
High Grade Intraepithelial Neoplasia

Explore related trials

Vulvar Intraepithelial NeoplasiaHPV

Where it's being run

5 sites across 3 states
Ohio3
Florida1
Indiana1

Who to contact

Mihaela Plesa
[email protected]
440-255-1155
Email the study team

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Do you actually qualify for this trial?

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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

What this trial measures

  • Number of participants with complete histologic response18 weeks

    Number of participants who have complete histologic response following topical artesunate ointment