Recruiting
Phase 2

Artesunate Ointment

Sponsor:

Frantz Viral Therapeutics, LLC

Code:

NCT06075264

Conditions

Vulvar Diseases

HPV Infection

Vulvar HSIL

Pre-Cancerous Dysplasia

HPV Disease

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Artesunate ointment

Placebo ointment

Study Details

Brief summary:

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).

Conditions

Vulvar Diseases

HPV Infection

Vulvar HSIL

Pre-Cancerous Dysplasia

HPV Disease

Study ID

NCT06075264

Start date

Dec 6, 2023

Status verified date

Aug, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

27 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Artesunate ointment

Artesunate formulated as topical ointment, 40% Four 5-day cycles of artesunate ointment every 2 weeks

placebo comparator: Placebo ointment

Placebo ointment Four 5-day cycles of placebo ointment every 2 weeks

Interventions

Artesunate ointment

topical ointment, as a non-surgical treatment

Placebo ointment

topical placebo ointment

Primary outcome measure

  • Number of participants with complete histologic response [ Time Frame: 18 weeks ]

Central Contacts and Locations

Central contacts

Mihaela Plesa

440-255-1155fvtinfo@frantzgroup.com

Ahmad Bayat, MD

301-956-2523

Locations

Florida Gynecologic Oncology

Recruiting

Fort Myers, Florida, United States, 33905

Contacts

Edward C. Grendys, MD FACOG, FACS

239-334-6626Edward.Grendys@usa.genesiscare.com

Ascension St. Vincent

Recruiting

Indianapolis, Indiana, United States, 46260

Contacts

Sarah Goodrich, MD

inindgynoncresearch@ascension.org

Principal Investigator:

Sarah Goodrich, MD

Cleveland Clinic Fairview Hospital

Recruiting

Cleveland, Ohio, United States, 44111

Contacts

Donna White

216-445-8090whited11@ccf.org

Megan Park

216-445-8090parkm2@ccf.org

Principal Investigator:

Chad Michener, MD

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Donna White

216-445-8090whited11@ccf.org

Megan Park

216-445-8090parkm2@ccf.org

Principal Investigator:

Chad Michener, MD

Hillcrest Hospital

Recruiting

Mayfield Heights, Ohio, United States, 44124

Contacts

Donna White

216-445-8090whited11@ccf.org

Megan Park

216-445-8090parkm2@ccf.org

Principal Investigator:

Chad Michener, MD

More Information

Sponsor

Frantz Viral Therapeutics, LLC

Last update posted

Aug 14, 2025

Last verified

Aug, 2025

Keywords

  • topical treatment
  • ointment
  • non-surgical
  • vulvar cancer prevention
  • high-risk HPV
  • human papillomavirus
  • HPV
  • vulvar HSIL
  • High grade lesions

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Frantz Viral Therapeutics, LLC on 2025-08-14.