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

February 20, 2024 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

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

27

Phase

  • 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 Backup

  • Name: Ahmad Bayat, MD
  • Phone Number: 301-956-2523

Study Locations

  • United States
    • Florida
      • Fort Myers, Florida, United States, 33905
    • 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

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
Intervention / Treatment
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

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

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

Frantz Viral Therapeutics, LLC

Collaborators

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)

December 6, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

October 4, 2023

First Submitted That Met QC Criteria

October 4, 2023

First Posted (Actual)

October 10, 2023

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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