RecruitingPhase 2NCT06075264

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)

Sponsor

Frantz Viral Therapeutics, LLC

Enrollment

27 participants

Start Date

Dec 6, 2023

Study Type

INTERVENTIONAL

Conditions

Vulvar Diseases HPV Infection High Grade Intraepithelial Neoplasia Pre-Cancerous Dysplasia Vulvar HSIL 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

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an artesunate ointment (originally derived from a malaria drug) applied directly to the vulva to treat high-grade vulvar dysplasia — abnormal cells on the outer female genitals caused by HPV that could progress to cancer if untreated. **You may be eligible if...** - You are a woman aged 18 or older - You have been diagnosed by biopsy with high-grade vulvar dysplasia (also called VIN2, VIN3, or vulvar HSIL), including new or recurrent cases - You are able and willing to attend follow-up visits **You may NOT be eligible if...** - You have not had a biopsy confirming the diagnosis - You are unable to follow up as required - You do not meet other medical eligibility criteria confirmed by the study team Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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