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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
27
topical ointment, as a non-surgical treatment
topical placebo ointment
Florida Gynecologic Oncology
Fort Myers, Florida, United States
RECRUITINGAscension St. Vincent
Indianapolis, Indiana, United States
RECRUITINGCleveland Clinic Fairview Hospital
Cleveland, Ohio, United States
RECRUITINGCleveland Clinic Foundation
Cleveland, Ohio, United States
RECRUITINGHillcrest Hospital
Mayfield Heights, Ohio, United States
RECRUITINGNumber of participants with complete histologic response
Number of participants who have complete histologic response following topical artesunate ointment
Time frame: 18 weeks
Number of participants who have achieved viral clearance
Number of participants who achieve clearance of HPV genotypes present at screening. These genotypes become undetectable over the study window.
Time frame: Week 18
Number of participants who show partial response
Number of participants with documented partial response following topical artesunate
Time frame: Week 18
Number of participants who have durable response
Number of participants with documented complete response who do not have recurrence of their vulvar HSIL over the study window
Time frame: Week 18
Incidence of Treatment-Emergent Adverse Events (TEAE)
Number of participants who report artesunate-related serious adverse events
Time frame: 8 weeks
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