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Recruiting NCT06075264

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

Phase II Interventional Vulvar Diseases HPV Infection Vulvar HSIL Pre-Cancerous Dysplasia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Artesunate ointment, Placebo ointment.
Who it may be relevant to
Registry conditions: Vulvar Diseases, HPV Infection, Vulvar HSIL, Pre-Cancerous Dysplasia. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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)

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).

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.

Interventions

  • Drug Artesunate ointment
    topical ointment, as a non-surgical treatment
  • Drug Placebo ointment
    topical placebo ointment

Primary outcome measures

  • Number of participants with complete histologic response [Time frame: 18 weeks]
Secondary outcome measures (4)
  • Number of participants who have achieved viral clearance [Time frame: Week 18]
  • Number of participants who show partial response [Time frame: Week 18]
  • Number of participants who have durable response [Time frame: Week 18]
  • Incidence of Treatment-Emergent Adverse Events (TEAE) [Time frame: 8 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 5 centers
  • Florida Gynecologic Oncology — Fort Myers
  • Ascension St. Vincent — Indianapolis
  • Cleveland Clinic Fairview Hospital — Cleveland
  • Cleveland Clinic Foundation — Cleveland
  • Hillcrest Hospital — Mayfield Heights

Identifiers

NCT: NCT06075264 · ART-VIN IIB · 23-889

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗