[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"vin-2-of-usual-type\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:vin-2-of-usual-type":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":40,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":62},"100521874","phase-2-phase-ii-study-of-artesunate-ointment-for-the-treatment-of-vulvar-high-grade-squamous-intraepithelial-lesions-vulvar-hsil-vin23-100521874",false,"NCT06075264","Phase II Study of Artesunate Ointment for the Treatment of Vulvar High Grade Squamous Intraepithelial Lesions (Vulvar HSIL, VIN2\u002F3)","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)","ART-VIN IIB","Inclusion Criteria:\n\n* Adult women age ≥ 18 years\n* Capable of informed consent\n* Able to collaborate with planned follow-up (transportation, compliance history, etc)\n* Biopsy diagnosis of high-grade vulvar dysplasia (VIN2, VIN3, VIN2\u002F3, 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.\n* Positive HPV test at study entry (any genotype).\n* Women of childbearing potential agree to use birth control during the dosing phase (through week 8).\n* Laboratory values at Screening of:\n\n  * Serum alanine transaminase (SGPT\u002FALT) \\\u003C 5 x upper limit of normal (ULN)\n  * Serum aspartate transaminase (SGOT\u002FAST) \\\u003C 5 x ULN\n  * Serum Bilirubin (total) \\\u003C 2.5 x ULN\n  * Serum Creatinine ≤ 1.5 x ULN\n* Weight ≥ 50kg\n\nExclusion Criteria:\n\n* Pregnant and nursing women\n* Concurrent anal, vulvar, or cervical cancer\n* HIV-positive participants with a CD4 count \\\u003C 200\n* Participants infected with HIV-1 if not on a stable, suppressive antiretroviral therapy (ART) regimen.\n* 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.\n* Currently receiving systemic chemotherapy or radiation therapy for another cancer.\n* Concomitant use of Efavirenz for HIV antiretroviral treatment\n* Concomitant use of strong UGT inhibitors\n* Concomitant use of imiquimod, cidofovir, or 5-fluorouracil (5-FU) for the duration of the study\n* Concurrent dermatological conditions affecting the vulva (e.g., herpetic lesion, Crohn's disease, hidradenitis suppurativa) or vulvar dermatoses (e.g., lichen sclerosis or planus, atopic dermatitis, genital atrophy).\n* Concurrent treatment with systemic corticosteroids","FEMALE","18 Years",{"count":20,"type":21},27,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","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\u002F3).",[27,28,29,30,31,32,33,34,35,36,37,38,39],"Vulvar Diseases","HPV Infection","Vulvar HSIL","Pre-Cancerous Dysplasia","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","High Grade Intraepithelial Neoplasia",[41,42,43,44,45,46,47,48,49],"topical treatment","ointment","non-surgical","vulvar cancer prevention","high-risk HPV","human papillomavirus","HPV","vulvar HSIL","High grade lesions","RECRUITING","2025-08-13",{"date":53,"type":54},"2025-08-14","ACTUAL",{"date":56,"type":54},"2023-12-06",{"date":58,"type":21},"2027-12",{"name":60,"class":61},"Frantz Viral Therapeutics, LLC","INDUSTRY",5]