[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pre-cancerous-dysplasia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pre-cancerous-dysplasia":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,59],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100370084","phase-2-artesunate-vaginal-inserts-for-the-treatment-of-cervical-intraepithelial-neoplasia-cin23-100370084",false,"NCT04098744","Artesunate Vaginal Inserts for the Treatment of Cervical Intraepithelial Neoplasia (CIN2\u002F3)","A Phase II Double Blind, Placebo-controlled, Randomized Trial of Artesunate Vaginal Inserts for the Treatment of Patients With Cervical Intraepithelial Neoplasia (CIN2\u002F3)","ART-CIN_IIB","Inclusion Criteria:\n\n* Adult females age ≥ 25 years\n* Capable of informed consent\n* Any HPV genotype detectable by DNA test\u002FHPV genotyping\n* Colposcopically-directed, histologically confirmed tissue diagnosis of cervical high grade squamous intraepithelial lesions (CIN2, CIN3, or CIN2\u002F3)\n* Women of childbearing potential agree to use birth control through week17 of the study.\n* Weight ≥ 50kg\n\nExclusion Criteria:\n\n* Pregnant and nursing women\n* Active autoimmune disease\n* Taking immunosuppressive medication\n* HIV seropositivity\n* Immunocompromised subjects\n* Evidence of concurrent cervical adenocarcinoma in situ\n* Concurrent malignancy except for nonmelanoma skin lesions, because treatment for other cancers have systemic effects","FEMALE","25 Years","100 Years",{"count":21,"type":22},78,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This is a phase II double blind, placebo-controlled, randomized study of Artesunate vaginal inserts for the treatment of women who have cervical high grade intraepithelial neoplasia (CIN2\u002F3).",[28,29,30,31,32],"CIN 2\u002F3","HPV Infection","Pre-Cancerous Dysplasia","Cervical Dysplasia","HPV Related Disease",[34,35,36,37,38,39,40,41,42,43,44,45],"treatment study","cancer prevention","non-surgical","HPV related disease","CIN","topical treatment","vaginal inserts","artesunate","artemisinin","non-invasive","high risk HPV","vaginal suppository","RECRUITING","2025-09-29",{"date":49,"type":50},"2025-10-02","ACTUAL",{"date":52,"type":50},"2020-09-09",{"date":54,"type":22},"2026-12-31",{"name":56,"class":57},"Frantz Viral Therapeutics, LLC","INDUSTRY",7,{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":11,"sex":17,"minAge":67,"maxAge":4,"enrollmentInfo":68,"targetDuration":4,"studyType":23,"phases":70,"briefSummary":71,"conditions":72,"keywords":84,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},"100521874","phase-2-phase-ii-study-of-artesunate-ointment-for-the-treatment-of-vulvar-high-grade-squamous-intraepithelial-lesions-vulvar-hsil-vin23-100521874","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","18 Years",{"count":69,"type":22},27,[25],"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).",[73,29,74,30,75,76,77,78,79,80,81,82,83],"Vulvar Diseases","Vulvar HSIL","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",[39,85,36,86,87,88,89,90,91],"ointment","vulvar cancer prevention","high-risk HPV","human papillomavirus","HPV","vulvar HSIL","High grade lesions","2025-08-13",{"date":94,"type":50},"2025-08-14",{"date":96,"type":50},"2023-12-06",{"date":98,"type":22},"2027-12",{"name":56,"class":57},5]