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

August 13, 2025 updated by: Frantz Viral Therapeutics, LLC

A Phase II Double-blind, Placebo-controlled, Randomized Trial of Topical Artesunate Ointment for the Treatment of Patients With Vulvar High-grade Squamous Intraepithelial Lesions (Vulvar HSIL)

This is a phase II double-blind, placebo-controlled study of artesunate ointment for the treatment of HPV-associated vulvar HSIL (usual type vulvar intraepithelial neoplasia 2/3).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Eligible participants in this study are randomized 2:1 to receive either artesunate or placebo ointment for the treatment of vulvar HSIL. Both groups receive four 5-day cycles of topical ointment, at weeks 0, 2, 4, and 6. Dosing visits may be done in person or as telehealth (ointment may be shipped directly to the patient). Participants are followed closely with vulvar examinations or colposcopies at weeks 8, 18, 6-months and 12-months.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Ahmad Bayat, MD
  • Phone Number: 301-956-2523

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Fort Myers, Florida, United States, 33905
    • Indiana
      • Indianapolis, Indiana, United States, 46260
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Foundation
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chad Michener, MD
        • Sub-Investigator:
          • Mariam AlHilli, MD
        • Sub-Investigator:
          • Steven Waggonner, MD
        • Sub-Investigator:
          • Robert DeBernardo, MD
        • Sub-Investigator:
          • Roberto Vargas, MD
        • Sub-Investigator:
          • Lindsey Beffa, MD
        • Sub-Investigator:
          • Johanna Kelley, MD
        • Sub-Investigator:
          • Daniel Margul, MD
        • Sub-Investigator:
          • Michelle Kuznicki, MD
      • Cleveland, Ohio, United States, 44111
        • Recruiting
        • Cleveland Clinic Fairview Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chad Michener, MD
        • Sub-Investigator:
          • Mariam AlHilli, MD
        • Sub-Investigator:
          • Steven Waggonner, MD
        • Sub-Investigator:
          • Robert DeBernardo, MD
        • Sub-Investigator:
          • Roberto Vargas, MD
      • Mayfield Heights, Ohio, United States, 44124
        • Recruiting
        • Hillcrest Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chad Michener, MD
        • Sub-Investigator:
          • Mariam AlHilli, MD
        • Sub-Investigator:
          • Steven Waggonner, MD
        • Sub-Investigator:
          • Robert DeBernardo, MD
        • Sub-Investigator:
          • Roberto Vargas, MD
        • Sub-Investigator:
          • Lindsey Beffa, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Artesunate ointment
Artesunate formulated as topical ointment, 40% Four 5-day cycles of artesunate ointment every 2 weeks
Drug: Artesunate ointment
topical ointment, as a non-surgical treatment
Other Names:
  • Artemisinin
  • Artesunic acid
  • Dihydroartemisinin (DHA)
Placebo Comparator: Placebo ointment
Placebo ointment Four 5-day cycles of placebo ointment every 2 weeks
Drug: Placebo ointment
topical placebo ointment
Other Names:
  • Placebo to artesunate ointment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants with complete histologic response
Time Frame: 18 weeks
Number of participants who have complete histologic response following topical artesunate ointment
18 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of participants who have achieved viral clearance
Time Frame: Week 18
Number of participants who achieve clearance of HPV genotypes present at screening. These genotypes become undetectable over the study window.
Week 18
Number of participants who show partial response
Time Frame: Week 18
Number of participants with documented partial response following topical artesunate
Week 18
Number of participants who have durable response
Time Frame: Week 18
Number of participants with documented complete response who do not have recurrence of their vulvar HSIL over the study window
Week 18
Incidence of Treatment-Emergent Adverse Events (TEAE)
Time Frame: 8 weeks
Number of participants who report artesunate-related serious adverse events
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Frantz Viral Therapeutics, LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 6, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 4, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 10, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ART-VIN IIB
  • 23-889 (Other Identifier: Cleveland Clinic IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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