NCT03792516

Artesunate Ointment for the Treatment of High Grade Vulvar Intraepithelial Neoplasia (HSIL VIN2/3)

A Phase I Proof-of-Concept Study of Artesunate Ointment for the Treatment of Patients With High-Grade Vulvar Intraepithelial Neoplasia (HSIL VIN 2/3)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: Female
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

Summary

This is a Phase I, proof-of-concept treatment study to evaluate the safety, tolerability and feasibility of topical artesunate ointment to treat high grade vulvar intraepithelial neoplasia (HSIL VIN2/3).

Detailed description

Phase I open-label dose escalation study of topical artesunate, formulated as ointment, in the treatment of adult females with biopsy-confirmed HSIL VIN2/3. Fifteen (15) subjects will undergo up to a total of three cycles of topical artesunate. The first cycle will be initiated on Day 0, the second at Week 2, and the third and final cycle at week 4. Primary Objective: To evaluate the safety and tolerability of artesunate ointment applied topically on VIN2/3 lesions To measure the effect of artesunate ointment on histologic regression of HSIL/VIN2/3 to VIN1 or less, confirmed by a colposcopically-directed biopsy, at study week 15.

Conditions

• Vulvar Dysplasia
• HPV-Related Vulvar Intraepithelial Neoplasia
• Preinvasive Vulvar Disease
• Vulva Intraepithelial Neoplasia
• Vulvar Diseases

Interventions

Type	Name	Description
DRUG	artesunate ointment 40%	artesunate formulated as an ointment to be applied topically to the vulva

Timeline

• Start date: 2019-04-17
• Primary completion: 2022-08-31
• Completion: 2024-12-03
• First posted: 2019-01-03
• Last updated: 2024-12-04

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study