NCT06075264

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

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Frantz Viral Therapeutics, LLC · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Vulvar Diseases
• HPV Infection
• Vulvar HSIL
• Pre-Cancerous Dysplasia
• HPV Disease
• VIN, Usual Type
• VIN 2 of Usual Type
• VIN 3 of Usual Type
• Vin II
• Vin III
• VIN Grade 2
• VIN Grade 3
• High Grade Intraepithelial Neoplasia

Interventions

Type	Name	Description
DRUG	Artesunate ointment	topical ointment, as a non-surgical treatment
DRUG	Placebo ointment	topical placebo ointment

Timeline

• Start date: 2023-12-06
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2023-10-10
• Last updated: 2025-08-14

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study