[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Frantz Viral Therapeutics, LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":127},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,58,99],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"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":20,"type":21},78,"ESTIMATED","INTERVENTIONAL",[24],"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).",[27,28,29,30,31],"CIN 2\u002F3","HPV Infection","Pre-Cancerous Dysplasia","Cervical Dysplasia","HPV Related Disease",[33,34,35,36,37,38,39,40,41,42,43,44],"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":48,"type":49},"2025-10-02","ACTUAL",{"date":51,"type":49},"2020-09-09",{"date":53,"type":21},"2026-12-31",{"name":55,"class":56},"Frantz Viral Therapeutics, LLC","INDUSTRY",7,{"id":59,"slug":4,"hasResults":10,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":10,"sex":16,"minAge":65,"maxAge":4,"enrollmentInfo":66,"targetDuration":4,"studyType":22,"phases":68,"briefSummary":69,"conditions":70,"keywords":82,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},"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":67,"type":21},27,[24],"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).",[71,28,72,29,73,74,75,76,77,78,79,80,81],"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",[38,83,35,84,85,86,87,88,89],"ointment","vulvar cancer prevention","high-risk HPV","human papillomavirus","HPV","vulvar HSIL","High grade lesions","2025-08-13",{"date":92,"type":49},"2025-08-14",{"date":94,"type":49},"2023-12-06",{"date":96,"type":21},"2027-12",{"name":55,"class":56},5,{"id":100,"slug":4,"hasResults":10,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":10,"sex":106,"minAge":65,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":22,"phases":109,"briefSummary":110,"conditions":111,"keywords":116,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":125,"locationsCount":126},"100531958","NCT06206564","Artesunate Ointment for the Treatment of Anal HSIL in HIV-negative Participants","A Phase II Double Blind, Placebo-controlled, Randomized Trial of Artesunate Ointment for the Treatment of HIV-negative Patients With Anal High-grade Squamous Intraepithelial Lesions (Anal HSIL)","ART-AIN IIB-2","Inclusion Criteria:\n\n* Adult men and women age ≥ 18 years\n* Capable of informed consent\n* Biopsy-confirmed intra-anal high-grade dysplasia (AIN 2, AIN 3, anal HSIL) by HRA.\n* Positive anal human papillomavirus (HPV) test.\n* Women of childbearing potential agree to use birth control for the duration of the study.\n* Laboratory values at Screening of:\n\n  1. Serum alanine transaminase (SGPT\u002FALT) \\\u003C 5 x upper limit of normal (ULN)\n  2. Serum aspartate transaminase (SGOT\u002FAST) \\\u003C 5 x ULN\n  3. Serum Bilirubin (total) \\\u003C 2.5 x ULN\n  4. Serum Creatinine ≤ 1.5 x ULN\n* Electrocardiogram (ECG) with no clinically significant findings as assessed by the Investigator.\n* Weight ≥ 50kg\n\nExclusion Criteria:\n\n* Pregnant and nursing women\n* Diagnosis of low-grade anal dysplasia (AIN 1, LSIL), without the concomitant diagnosis of anal HSIL, by HRA\n* Concurrent anal, vulvar, cervical, or penile cancer\n* HIV-seropositivity\n* Currently receiving systemic chemotherapy or radiation therapy for another cancer.\n* Patients who are on medical treatment with systemic immunosuppressants or steroids (e.g., active autoimmune disease). Participants using nasal steroid treatments for allergic conditions may participate in the study.\n* Concomitant use of strong UGT (Uridine-diphosphate-glucuronosyltransferase) inhibitors\n* Concomitant use of imiquimod or 5-fluorouracil (5-FU) for the duration of the study","ALL",{"count":108,"type":21},48,[24],"This is a phase II double blind, placebo-controlled, randomized study of artesunate ointment for the treatment of HIV-negative men and women who have anal high grade squamous intraepithelial lesions (anal HSIL)",[112,113,114,115],"Anal High-grade Squamous Intraepithelial Lesion","Anal HSIL","Anal HPV Infection","AIN",[117,118,35],"intra-anal","topical","2025-05-14",{"date":121,"type":49},"2025-05-18",{"date":123,"type":49},"2024-01-12",{"date":53,"type":21},{"name":55,"class":56},2,""]