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Clinical Trial 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).


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06075264
Study type Interventional
Source Frantz Viral Therapeutics, LLC
Contact Mihaela Plesa
Phone 440-255-1155
Email mplesa@frantzgroup.com
Status Recruiting
Phase Phase 2
Start date December 6, 2023
Completion date December 2025

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