[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100531958":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":35,"locations":45,"responsibleParty":89,"collaborators":91,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":98,"sex":104,"minAge":105,"maxAge":11,"enrollmentInfo":106,"targetDuration":11,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":118,"overallStatus":48,"whyStopped":11,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"Frantz Viral Therapeutics, LLC","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Artesunate","EXPERIMENTAL",null,[13],"Drug: Artesunate ointment",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo ointment","PLACEBO_COMPARATOR",[18],"Drug: Placebo",[20,29],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Artesunate ointment","Four 5-day cycles of artesunate ointment given at weeks 0, 2, 4, 6",[9],[26,27,28],"Artesunic acid","Dihydroartemisinin (DHA)","Artemisinin",{"type":21,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Placebo","Four 5-day cycles of placebo ointment given at weeks 0, 2, 4, 6",[15],[34],"placebo ointment",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":11,"email":40},"Mihaela Plesa","CONTACT","440-255-1155","fvtinfo@frantzgroup.com",{"name":42,"role":38,"phone":43,"phoneExt":11,"email":44},"Ahmad Bayat, MD","301-956-2523","ahmadb@amarexcro.com",[46,73],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Anal Dysplasia Clinic MidWest","RECRUITING","Chicago","Illinois","60614","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-87.65005,41.85003,{"lat":58,"lon":57},[61,65,68,70],{"name":62,"role":38,"phone":63,"phoneExt":11,"email":64},"Gary Bucher, MD","312-623-2625","garybuchermd@adcmidwest.com",{"name":66,"role":38,"phone":67,"phoneExt":11,"email":11},"Emily Miller","3126232625",{"name":62,"role":69,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"name":71,"role":72,"phone":11,"phoneExt":11,"email":11},"Emily Miller, APN","SUB_INVESTIGATOR",{"facility":74,"status":48,"city":75,"state":75,"zip":76,"country":52,"countryCode":53,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Laser Surgery Care","New York","10011",{"type":55,"coordinates":78},[79,80],-74.00597,40.71427,{"lat":80,"lon":79},[83,87],{"name":84,"role":38,"phone":85,"phoneExt":11,"email":86},"Taylor Ridley","212-242-6500","tridley@lasersurgerycare.com",{"name":88,"role":69,"phone":11,"phoneExt":11,"email":11},"Joseph Terlizzi, MD",{"type":90,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[92,95],{"name":93,"class":94},"Laser Surgery Care, LLC","UNKNOWN",{"name":47,"class":94},"100531958","phase-2-artesunate-ointment-for-the-treatment-of-anal-hsil-in-hiv-negative-participants-100531958",false,"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","18 Years",{"count":107,"type":108},48,"ESTIMATED","INTERVENTIONAL",[111],"PHASE2","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)",[114,115,116,117],"Anal High-grade Squamous Intraepithelial Lesion","Anal HSIL","Anal HPV Infection","AIN",[119,120,121],"intra-anal","topical","non-surgical","2025-05-14",{"date":124,"type":125},"2025-05-18","ACTUAL",{"date":127,"type":125},"2024-01-12",{"date":129,"type":108},"2026-12-31",{"name":5,"class":6},2]