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

Study acronym: ART-VIN IIB
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Dec 2025 to Dec 2026
    • Study completion date: Dec 2026 to Dec 2027
    v9
  2. Primary completion date: Dec 2024 to Dec 2025
    • Study completion date: Dec 2025 to Dec 2026
    • Site details revised at 1 of 5 sites
    v8
  3. Study sites: 4 to 5v7
  4. Re-verified, no change to tracked fieldsv6
  5. Site details revised at 1 of 4 sitesv5
Show 3 earlier versionsHide 3 earlier versions
  1. Re-verified, no change to tracked fieldsv4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Oct 2024 to Dec 2024
    • Start date changed from estimate of Nov 2023 to Dec 6, 2023
    • Site details revised at 4 of 4 sites
    v3
  3. Study sites: 3 to 4
    • Start date: Oct 2023 to Nov 2023
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06075264
Lead Sponsor Frantz Viral Therapeutics, LLC
Collaborators: The Cleveland Clinic
Conditions
(from sponsor)		 Vulvar Diseases, HPV Infection, Vulvar HSIL, Pre-Cancerous Dysplasia, HPV Disease, VIN, Usual Type, VIN 2 of Usual Type, VIN 3 of Usual Type +5 more
Related terms Papillomavirus Infections, Vulvar Diseases
Enrollment 27 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov