[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579943":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":31,"locations":37,"responsibleParty":131,"collaborators":133,"id":137,"slug":138,"hasResults":139,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":30,"eligibilityCriteria":143,"healthyVolunteers":139,"sex":144,"minAge":145,"maxAge":30,"enrollmentInfo":146,"targetDuration":30,"studyType":149,"phases":150,"briefSummary":153,"conditions":154,"keywords":156,"overallStatus":40,"whyStopped":30,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":170},{"fullName":5,"class":6},"Azitra Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ATR04-484","EXPERIMENTAL","Topically applied ATR04-484",[13],"Drug: ATR04-484",{"label":15,"type":16,"description":17,"interventionNames":18},"Vehicle","PLACEBO_COMPARATOR","Topically applied vehicle",[19],"Drug: Vehicle",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","ATR04-484 is a recombinant live biotherapeutic product (rLBP) containing the engineered S. epidermidis strain SE484 in an ointment formulation for topical use",[9],[26],"ATR-04",{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"Topically applied vehicle.",[15],null,[32],{"name":33,"role":34,"phone":35,"phoneExt":30,"email":36},"Mary Spellman, MD","CONTACT","415-652-7962","spellman@azitrainc.com",[38,58,72,86,101,116],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Genesis Cancer and Blood Institute","RECRUITING","Hot Springs","Arkansas","71913","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-93.05518,34.5037,{"lat":50,"lon":49},[53],{"name":54,"role":34,"phone":55,"phoneExt":56,"email":57},"Laura,","501-624-7700","63839","Laura.Sellers@aoncology.com",{"facility":59,"status":40,"city":60,"state":61,"zip":62,"country":44,"countryCode":45,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Yale University School of Medicine","New Haven","Connecticut","06510",{"type":47,"coordinates":64},[65,66],-72.92816,41.30815,{"lat":66,"lon":65},[69],{"name":70,"role":34,"phone":71,"phoneExt":30,"email":30},"Devon, Clinical Research Coordinator","203-785-2270",{"facility":73,"status":40,"city":74,"state":74,"zip":75,"country":44,"countryCode":45,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"NYU Langone","New York","10016",{"type":47,"coordinates":77},[78,79],-74.00597,40.71427,{"lat":79,"lon":78},[82],{"name":83,"role":34,"phone":84,"phoneExt":30,"email":85},"Sevinj, Sr. Clinical Research Coordinator","212-263-5244","Sevinj.Sasunova@nyulangone.org",{"facility":87,"status":40,"city":88,"state":89,"zip":90,"country":44,"countryCode":45,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"The Ohio State University","Gahanna","Ohio","43230",{"type":47,"coordinates":92},[93,94],-82.87934,40.01923,{"lat":94,"lon":93},[97],{"name":98,"role":34,"phone":99,"phoneExt":30,"email":100},"Elizabeth, Clinical Research Coordinator","614-293-9306","Elizabeth.Begle@osumc.edu",{"facility":102,"status":40,"city":103,"state":104,"zip":105,"country":44,"countryCode":45,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"MD Anderson","Houston","Texas","77030",{"type":47,"coordinates":107},[108,109],-95.36327,29.76328,{"lat":109,"lon":108},[112],{"name":113,"role":34,"phone":114,"phoneExt":30,"email":115},"Angelica, Sr. Coordinator, Clinical Research","832-846-0794","ARRodriguez3@mdanderson.org",{"facility":117,"status":40,"city":118,"state":119,"zip":120,"country":44,"countryCode":45,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"Inova Schar Cancer","Fairfax","Virginia","22031",{"type":47,"coordinates":122},[123,124],-77.30637,38.84622,{"lat":124,"lon":123},[127],{"name":128,"role":34,"phone":129,"phoneExt":30,"email":130},"Stephanie, Senior Director, Clinical Trials Office","571-472-4724","Stephanie.vanbebber@inova.org",{"type":132,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[134],{"name":135,"class":136},"Prosoft Clinical","OTHER","100579943","phase-1-a-study-to-evaluate-topical-atr04-484-for-egfri-associated-dermal-toxicity-100579943",false,"NCT06830863","A Study to Evaluate Topical ATR04-484 for EGFRi-Associated Dermal Toxicity","A Phase 1\u002F2, Multicenter, Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety, Bioavailability, and Effect of Topically Administered ATR04-484 for Moderate to Severe EGFRi-Associated Dermal Toxicity","Inclusion Criteria:\n\n* Adults ≥18 years of age\n* Has Grade 2 or 3 non-infected moderate to severe EGFRi-related dermal toxicity affecting the face (the neck, chest, back and other areas may also be affected)\n\nExclusion Criteria:\n\n* Significant skin disease other than EGFRi-related dermal toxicity\n* Treatment with topical mid- to high-potency topical corticosteroids, or topical antibiotics or antibacterial washes on the face, neck, chest, or back within 14 days prior to baseline; treatment with systemic antibiotics or systemic corticosteroids within 14 days prior to baseline\n* Residing with an immunocompromised person residing with them in the same dwelling from the baseline visit through 2 weeks after the treatment period","ALL","18 Years",{"count":147,"type":148},32,"ESTIMATED","INTERVENTIONAL",[151,152],"PHASE1","PHASE2","The goal of this randomized clinical trial is to learn if topical treatment with ATR04-484 can treat skin rash in patients undergoing EGFR inhibitor (EGFRi) therapy. The primary goal of the study is to determine safety and tolerability of ATR04-484, and the secondary goal of the study is to assess efficacy signals of ATR04-484. Researchers will compare treatment of ATR04-484 to its vehicle. Participants will:\n\n* Apply ATR04-484 or vehicle daily for 28 days\n* Visit the clinic periodically for evaluation and sample collection",[155],"EGFR Inhibitor-associated Rash",[157,158,159,160],"EGFR","acneiform","EGFR inhibitor-associated rash","EGFRi","2026-02-09",{"date":163,"type":164},"2026-02-11","ACTUAL",{"date":166,"type":164},"2025-08-25",{"date":168,"type":148},"2027-02-15",{"name":5,"class":6},6]