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

Completed · Phase 1

Conditions studied: Vulvar Dysplasia, HPV-Related Vulvar Intraepithelial Neoplasia, Preinvasive Vulvar Disease, Vulva Intraepithelial Neoplasia, Vulvar Diseases

In brief

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).

Key facts

Study ID

NCT03792516

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

15

Starts

2019-04-17

Expected to finish

2024-12-03

Last updated by the study team

2024-12-04

Who can join

Age: 18 and older, up to 100. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Colposcopically-directed biopsy diagnosis of high-grade vulvar dysplasia (VIN2, VIN3, VIN2/3, HSIL), including both new and recurrent disease.
• Females of childbearing potential: negative urine pregnancy test
• Ability to provide informed consent
• Ability to collaborate with planned follow-up (transportation, compliance history, etc.)
• Use of contraception through the study exit visit (week 28)

You may not qualify if…

• Concomitant use of any topical immune modulating agents e.g. imiquimod, Aldara ®
• Cluster of differentiation 4 (CD4) count < 200 at the time of screening for eligibility.
• Unable to provide informed consent
• Currently receiving systemic chemotherapy or radiation therapy for another cancer.
• Pregnant females
• Concurrent dermatological disorders involving the vulva (i.e., herpes, ulceration secondary to Crohn's disease) or vulvar dermatosis (i.e., lichen planus, lichen sclerosus, or lichen simplex chronicus);
• Women weighing less than 50 kg

Where it is running

• Johns Hopkins Outpatient Center — Baltimore, Maryland, United States
• Cleveland Clinic Fairview Hospital — Cleveland, Ohio, United States
• Cleveland Clinic Foundation - Main Campus — Cleveland, Ohio, United States
• Cleveland Clinic - Hillcrest Hospital — Mayfield Heights, Ohio, United States

Full record on ClinicalTrials.gov

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