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Anti-metabolites

Artesunate Ointment for Vulvar Precancerous Lesions (ART-VIN Trial)

Phase 1
Waitlist Available
Led By Cornelia L Trimble, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Females of childbearing potential: negative urine pregnancy test
Colposcopically-directed biopsy diagnosis of high-grade vulvar dysplasia (VIN2, VIN3, VIN2/3, HSIL), including both new and recurrent disease.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 weeks
Awards & highlights

ART-VIN Trial Summary

This trial is testing a new ointment to treat precancerous cells on the vulva. The goal is to see if it is safe and works well.

Who is the study for?
This trial is for women with a biopsy-confirmed diagnosis of high-grade vulvar dysplasia, including new and recurrent cases. Participants must be able to get pregnant but not currently be pregnant, use contraception through week 28, and commit to follow-up visits. Women under 50 kg or with certain other health conditions are excluded.Check my eligibility
What is being tested?
The study is testing the safety and effectiveness of a topical ointment containing 40% artesunate in treating high-grade vulvar intraepithelial neoplasia (HSIL VIN2/3). It's an early-stage trial designed to see if this treatment could work and what side effects it might have.See study design
What are the potential side effects?
Since this is a Phase I trial primarily focused on safety and tolerability, specific side effects of the artesunate ointment are being investigated. Potential side effects will become clearer as the study progresses.

ART-VIN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am of childbearing age and my pregnancy test is negative.
Select...
I have been diagnosed with a severe precancerous condition of the vulva.

ART-VIN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and tolerability of artesunate ointment applied topically on VIN2/3 lesions as assessed by number of participants experiencing serious adverse events or dose-limiting toxicities
Secondary outcome measures
Effect of artesunate ointment as assessed by number of participants with regression to VIN1 or less at week 15

ART-VIN Trial Design

3Treatment groups
Experimental Treatment
Group I: Artesunate ointment 40%, 3 cyclesExperimental Treatment1 Intervention
Patients enrolled in this treatment group will receive three 5-day cycles of artesunate ointment applied topically to the vulva at weeks 0, 2, and 4.
Group II: Artesunate ointment 40%, 2 cyclesExperimental Treatment1 Intervention
Patients enrolled in this treatment group will receive two 5-day cycles of artesunate ointment applied topically to the vulva at weeks 0 and 2.
Group III: Artesunate ointment 40%, 1 cycleExperimental Treatment1 Intervention
Patients enrolled in this treatment group will receive one 5-day cycle of artesunate ointment applied topically to the vulva at week 0.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
557 Previous Clinical Trials
32,885 Total Patients Enrolled
Frantz Viral Therapeutics, LLCIndustry Sponsor
5 Previous Clinical Trials
219 Total Patients Enrolled
Cornelia L Trimble, MDPrincipal InvestigatorJohns Hopkins University
2 Previous Clinical Trials
162 Total Patients Enrolled

Media Library

Artesunate Ointment (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT03792516 — Phase 1
Vulvar Disease Research Study Groups: Artesunate ointment 40%, 2 cycles, Artesunate ointment 40%, 1 cycle, Artesunate ointment 40%, 3 cycles
Vulvar Disease Clinical Trial 2023: Artesunate Ointment Highlights & Side Effects. Trial Name: NCT03792516 — Phase 1
Artesunate Ointment (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03792516 — Phase 1

Frequently Asked Questions

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

Could you please elaborate on the research conducted around artesunate ointment 40%?

"Artesunate ointment 40% was initially trialed in 2017 at University Hospitals of Derby and Burton NHS Foundation Trust. As of now, 114 trials have concluded with 11 still ongoing, many out of Mayfield Heights, Maryland."

Answered by AI

Does this research include people under the age of forty?

"This medical trial is accepting participants from the age of majority to centenarians."

Answered by AI

Are there unfilled slots available in this medical trial?

"At this time, recruitment for this trial has been paused. The initial posting date was April 17th 2019 and the most recent update occurred on October 31st 2022. If you are seeking other clinical trials, 2449 studies concerning vulvar diseases remain open to participants, as well as 11 research projects focused on artesunate ointment 40%."

Answered by AI

For whom is this research opportunity available?

"For consideration into this clinical trial, applicants must be diagnosed with a vulvar disorder and fall between the ages of 18-100. The study is currently looking to enrol 15 individuals."

Answered by AI

What potential risks exist from utilizing artesunate ointment 40%?

"Due to the fact that this is an experimental Phase 1 trial, our team at Power has assigned artesunate ointment 40% with a safety rating of 1. This reflects the limited data available supporting its efficacy and safety."

Answered by AI

How many people are taking part in this experimental program?

"Unfortunately, this clinical trial is not currently onboarding participants. It was first posted on April 17th 2019 and the latest amendment to its protocol occurred on October 31st 20202. If you wish to join another study, 2449 studies seeking patients with vulvar diseases are recruiting, as well as 11 trials for artesunate ointment 40%."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Artesunate Ointment for the Treatment of High Grade Vulvar Intraepithelial Neoplasia (HSIL VIN2/3)
2019. "Artesunate Ointment for the Treatment of High Grade Vulvar Intraepithelial Neoplasia (HSIL VIN2/3)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03792516.
~2 spots leftby Apr 2025
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