NCT06075264 Phase II Study of Artesunate Ointment for the Treatment of Vulvar High Grade Squamous Intraepithelial Lesions (Vulvar HSIL, VIN2/3)
| NCT ID | NCT06075264 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Frantz Viral Therapeutics, LLC |
| Condition | Vulvar Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 27 participants |
| Start Date | 2023-12-06 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 27 participants in total. It began in 2023-12-06 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06075264 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Vulvar Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06075264 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06075264 currently recruiting?
Yes, NCT06075264 is actively recruiting participants. Contact the research team at fvtinfo@frantzgroup.com for enrollment information.
Where is the NCT06075264 trial being conducted?
This trial is being conducted at Fort Myers, United States, Indianapolis, United States, Cleveland, United States, Cleveland, United States and 1 additional location.
Who is sponsoring the NCT06075264 clinical trial?
NCT06075264 is sponsored by Frantz Viral Therapeutics, LLC. The trial plans to enroll 27 participants.