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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).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 18

Awards & highlights

ART-VIN IIB Trial 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.Check my eligibility

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.See study design

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.

ART-VIN IIB Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

ART-VIN IIB Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 18

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 18

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 18 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with complete histologic response

Secondary outcome measures

Incidence of Treatment-Emergent Adverse Events (TEAE)

Number of participants who have achieved viral clearance

Number of participants who have durable response

+1 more

ART-VIN IIB Trial 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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Frantz Viral Therapeutics, LLCLead Sponsor

5 Previous Clinical Trials

207 Total Patients Enrolled

The Cleveland ClinicOTHER

1,030 Previous Clinical Trials

1,365,531 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what degree is Artesunate ointment hazardous to users?

"The safety of Artesunate ointment was assessed to be a 2 on our rating scale, as Phase 2 trials indicate that there is some evidence for its security but none supporting the ointment's effectiveness."

Answered by AI

Is the research project presently looking for new participants?

"According to information accessible on clinicaltrials.gov, this trial has stopped recruiting participants - the original post being published in October 1st 2023 and last updated four days later. However, there are 122 other trials that require volunteers at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Phase II Study of Artesunate Ointment for the Treatment of Vulvar High Grade Squamous Intraepithelial Lesions (Vulvar HSIL, VIN2/3)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06075264.

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