Topical treatment for high-grade vulvar lesions
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 study is testing a new ointment to see if it can help women with high-grade vulvar lesions caused by HPV without needing surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 27 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Frantz Viral Therapeutics, LLC Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 5 sites (Fort Myers, Florida and 4 other locations) |
| Trial ID | NCT06075264 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adult women aged 18 and older with a biopsy-confirmed diagnosis of high-grade vulvar dysplasia and a positive HPV test.
Not a fit: Patients with concurrent anal, vulvar, or cervical cancer, as well as those who are pregnant or nursing, will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a non-invasive option for women with vulvar HSIL, potentially preventing progression to cancer.
How similar studies have performed: While this approach is novel, similar studies targeting HPV-related lesions have shown promise in other contexts.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Fort Myers, Florida and 4 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.