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)

What this Trial Is About

Researchers are evaluating the use of artesunate ointment as a treatment for vulvar high-grade squamous intraepithelial lesions (HSIL), which are precancerous changes often linked to HPV infection. This phase II trial compares artesunate ointment with a placebo ointment to assess their effects on these vulvar lesions. The study is double-blind and placebo-controlled to ensure objective results regarding the treatment's impact on vulvar HSIL. Participants are randomly assigned in a 2:1 ratio to receive either a 40% artesunate ointment or a placebo ointment. Both groups apply their assigned ointment in four cycles, each lasting 5 days, spaced two weeks apart at weeks 0, 2, 4, and 6. These dosing visits can be conducted in person or via telehealth, with ointment shipped directly to the participant if needed. Follow-up visits involving vulvar exams or colposcopies occur at weeks 8, 18, 6 months, and 12 months after treatment begins. During the study, participants will have vulvar examinations and biopsies to monitor lesion response and HPV viral clearance. Researchers will track the number of participants achieving complete histologic response at 18 weeks as the primary outcome. Secondary measures include partial response, durable response, viral clearance, and treatment-related side effects. Participants must agree to follow-up visits and certain testing, including an excisional procedure at week 18 if needed. The total study duration includes treatment and follow-up visits extending up to 12 months.

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