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

Description

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, VIN, Usual Type, VIN 2 of Usual Type, VIN 3 of Usual Type, Vin II, Vin III, VIN Grade 2, VIN Grade 3, High Grade Intraepithelial Neoplasia

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Study Overview

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Study Details

Study overview

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).

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)

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

Condition
Vulvar Diseases
Intervention / Treatment

-

Contacts and Locations

Fort Myers

Florida Gynecologic Oncology, Fort Myers, Florida, United States, 33905

Indianapolis

Ascension St. Vincent, Indianapolis, Indiana, United States, 46260

Cleveland

Cleveland Clinic Fairview Hospital, Cleveland, Ohio, United States, 44111

Cleveland

Cleveland Clinic Foundation, Cleveland, Ohio, United States, 44195

Mayfield Heights

Hillcrest Hospital, Mayfield Heights, Ohio, United States, 44124

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Frantz Viral Therapeutics, LLC,

Study Record Dates

2025-12