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Anti-malarial Agent
Artesunate Ointment for Vulvar Precancer (ART-VIN IIB Trial)
Phase 2
Recruiting
Research Sponsored by Frantz Viral Therapeutics, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Weight ≥ 50kg
Positive HPV test at study entry (any genotype).
Must not have
Concomitant use of strong UGT inhibitors
Concurrent anal, vulvar, or cervical cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 18
Summary
This trial tests a new ointment to treat HPV-related vulvar precancer.
Who is the study for?
This trial is for adult women over 18 with a positive HPV test and biopsy-confirmed high-grade vulvar dysplasia (VIN2/3, HSIL). They must be able to consent, follow the study plan, not be pregnant or nursing, have no severe liver or kidney issues, weigh at least 50kg, and agree to use birth control. Excluded are those with low CD4 counts if HIV-positive, on certain HIV treatments or strong UGT inhibitors, using systemic corticosteroids or other cancer treatments.
What is being tested?
The study tests artesunate ointment versus placebo in treating HPV-associated vulvar HSIL. It's a phase II trial where participants don't know which treatment they're getting (double-blind) and neither do the researchers (placebo-controlled). The goal is to see if artesunate can effectively treat these lesions.
What are the potential side effects?
While specific side effects of artesunate ointment aren't listed here, common ones may include local skin reactions like redness or irritation at the application site. Systemic side effects are less likely due to topical administration.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I weigh at least 50kg.
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I tested positive for HPV.
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I am a woman aged 18 or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not taking any strong UGT inhibitors.
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I do not have anal, vulvar, or cervical cancer.
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I am HIV-positive with a CD4 count below 200.
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I am not willing to have surgery at week 18 to remove or check the progress of a lesion.
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I am not currently undergoing chemotherapy or radiation for another cancer.
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I am currently taking Efavirenz for HIV.
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I am currently taking corticosteroids.
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I have skin conditions affecting my vulva, like herpes or eczema.
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I am not using imiquimod, cidofovir, or 5-FU during the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 18
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 18
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants with complete histologic response
Secondary study objectives
Incidence of Treatment-Emergent Adverse Events (TEAE)
Number of participants who have achieved viral clearance
Number of participants who have durable response
+1 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: Artesunate ointmentActive Control1 Intervention
Artesunate formulated as topical ointment, 40% Four 5-day cycles of artesunate ointment every 2 weeks
Group II: Placebo ointmentPlacebo Group1 Intervention
Placebo ointment Four 5-day cycles of placebo ointment every 2 weeks
Find a Location
Who is running the clinical trial?
Frantz Viral Therapeutics, LLCLead Sponsor
5 Previous Clinical Trials
176 Total Patients Enrolled
The Cleveland ClinicOTHER
1,057 Previous Clinical Trials
1,371,733 Total Patients Enrolled