Topical treatment for high-grade vulvar lesions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II study evaluates the effectiveness of artesunate ointment in treating HPV-associated vulvar high-grade squamous intraepithelial lesions (HSIL). Participants are randomly assigned to receive either the artesunate ointment or a placebo over four cycles, with follow-up examinations to assess treatment outcomes. The study aims to provide a non-surgical option for women diagnosed with vulvar HSIL, focusing on safety and efficacy. Dosing visits can be conducted in person or via telehealth, enhancing accessibility for participants.

Why it matters

Who can join: the full rules

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

Where it's running

• Florida Gynecologic Oncology
  Fort Myers, Florida, United States Recruiting
• Ascension St. Vincent
  Indianapolis, Indiana, United States Recruiting
• Cleveland Clinic Fairview Hospital
  Cleveland, Ohio, United States Recruiting
• Cleveland Clinic Foundation
  Cleveland, Ohio, United States Recruiting
• Hillcrest Hospital
  Mayfield Heights, Ohio, United States Recruiting

Study contacts

• Study coordinator: Mihaela Plesa
• Email: fvtinfo@frantzgroup.com
• Phone: 440-255-1155

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.