Phase II Study of Artesunate Ointment for the Treatment of Vulvar High Grade Squamous Intraepithe⦠(NCT06075264) | Clinical Trial Compass
RecruitingPhase 2
Phase II Study of Artesunate Ointment for the Treatment of Vulvar High Grade Squamous Intraepithelial Lesions (Vulvar HSIL, VIN2/3)
United States27 participantsStarted 2023-12-06
Plain-language 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).
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* Adult women age ā„ 18 years
* Capable of informed consent
* Able to collaborate with planned follow-up (transportation, compliance history, etc)
* Biopsy diagnosis of high-grade vulvar dysplasia (VIN2, VIN3, VIN2/3, HSIL), including both new and recurrent disease. A biopsy diagnosis of vulvar high-grade squamous intraepithelial lesion within the previous 3 months which was not excised or otherwise treated may be accepted for study entry.
* Positive HPV test at study entry (any genotype).
* Women of childbearing potential agree to use birth control during the dosing phase (through week 8).
* Laboratory values at Screening of:
* Serum alanine transaminase (SGPT/ALT) \< 5 x upper limit of normal (ULN)
* Serum aspartate transaminase (SGOT/AST) \< 5 x ULN
* Serum Bilirubin (total) \< 2.5 x ULN
* Serum Creatinine ⤠1.5 x ULN
* Weight ā„ 50kg
Exclusion Criteria:
* Pregnant and nursing women
* Concurrent anal, vulvar, or cervical cancer
* HIV-positive participants with a CD4 count \< 200
* Participants infected with HIV-1 if not on a stable, suppressive antiretroviral therapy (ART) regimen.
* Unwillingness to undergo an excisional procedure at week 18 to either remove HSIL lesions, or to document histologic regression at a site where HSIL was present at study entry.
* Currently receiving systemic chemotherapy or radiation therapy for another cancer.
* Concomitant use of Efavirenz for HIV antiretroviral treatment
* Concomitant use of strong UGT inhibitoā¦
What they're measuring
1
Number of participants with complete histologic response