[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100536145":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":46,"centralContacts":50,"locations":57,"responsibleParty":87,"collaborators":28,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":28,"eligibilityCriteria":95,"healthyVolunteers":91,"sex":96,"minAge":97,"maxAge":28,"enrollmentInfo":98,"targetDuration":28,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":107,"overallStatus":60,"whyStopped":28,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Innovaderm Research Inc.","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"ruxolitinib 1.5% cream (Sequence 1)","EXPERIMENTAL","ruxolitinib 1.5% cream without occlusion for Area 1 and ruxolitinib 1.5% cream under occlusion at night for Area 2",[13,14,15],"Drug: Ruxolitinib 1.5% cream","Procedure: Application without occlusion in Area 1","Procedure: Application under occlusion at night in Area 2",{"label":17,"type":10,"description":18,"interventionNames":19},"ruxolitinib 1.5% cream ( Sequence 2)","ruxolitinib 1.5% cream under occlusion at night for Area 1 and ruxolitinib 1.5% cream without occlusion for Area 2",[13,20,21],"Procedure: Application under occlusion at night in Area 1","Procedure: Application without occlusion in Area 2",[23,29,34,38,42],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Ruxolitinib 1.5% cream","Topical application of Ruxolitinib 1.5% cream",[17,9],null,{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":28},"PROCEDURE","Application without occlusion in Area 1","Apply Ruxolitinib 1.5% cream on the discoid lupus erythematosus lesion without occlusion on Area 1.",[9],{"type":30,"name":35,"description":36,"armGroupLabels":37,"otherNames":28},"Application under occlusion at night in Area 2","Apply Ruxolitinib 1.5% cream on the discoid lupus erythematosus lesion under occlusion at night on Area 2.",[9],{"type":30,"name":39,"description":40,"armGroupLabels":41,"otherNames":28},"Application under occlusion at night in Area 1","Apply Ruxolitinib 1.5% cream on the discoid lupus erythematosus lesion under occlusion at night on Area 1.",[17],{"type":30,"name":43,"description":44,"armGroupLabels":45,"otherNames":28},"Application without occlusion in Area 2","Apply Ruxolitinib 1.5% cream on the discoid lupus erythematosus lesion without occlusion on Area 2.",[17],[47],{"name":48,"affiliation":5,"role":49},"Robert Bissonnette, MD","PRINCIPAL_INVESTIGATOR",[51],{"name":52,"role":53,"phone":54,"phoneExt":55,"email":56},"Fareheen Chowdhury","CONTACT","514-521-4285","341","fchowdhury@innovaderm.com",[58,75],{"facility":59,"status":60,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"INNO-6051 Site 03","RECRUITING","Fredericton","New Brunswick","E3B 1G9","Canada","CA",{"type":67,"coordinates":68},"Point",[69,70],-66.66558,45.94541,{"lat":70,"lon":69},[73],{"name":74,"role":53,"phone":28,"phoneExt":28,"email":28},"Melissa Bernal",{"facility":5,"status":60,"city":76,"state":77,"zip":78,"country":64,"countryCode":65,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Montreal","Quebec","H2X 2V1",{"type":67,"coordinates":80},[81,82],-73.58781,45.50884,{"lat":82,"lon":81},[85],{"name":86,"role":53,"phone":28,"phoneExt":28,"email":28},"Lydia Edjekouane",{"type":88,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100536145","phase-2-study-to-evaluate-the-efficacy-of-ruxolitinib-15-cream-in-adult-subjects-with-discoid-lupus-erythematosus-100536145",false,"NCT06261021","Study to Evaluate the Efficacy of Ruxolitinib 1.5% Cream in Adult Subjects with Discoid Lupus Erythematosus","A Phase 2, Single-Blind, Intraindividual Study to Evaluate the Efficacy of Ruxolitinib 1.5% Cream in Adult Subjects with Discoid Lupus Erythematosus","Inclusion Criteria:\n\n* Male or female subject 18 years of age or older at the time of consent.\n* Confirmed DLE diagnosis.\n* Subject has moderate to severe DLE, as defined by an overall CLA IGA score of 3 (moderate) or 4 (severe) at screening and Day 1.\n* Female subject of childbearing potential must have a negative urine pregnancy test at screening and negative urine pregnancy test at Day 1.\n* Subject has no known history of latent or active tuberculosis (TB) infection.\n* Subject is willing to participate and is capable of giving informed consent. Note: Consent must be obtained prior to any study-related procedures.\n* Subjects must be willing to comply with all study procedures and must be available for the duration of the study.\n\nExclusion Criteria:\n\n* Female subject who is breastfeeding, pregnant, or who is planning to become pregnant during the study.\n* Subject has a history of skin disease or presence of skin condition that would interfere with the study assessments.\n* Subject has unstable or fluctuating use of nicotine-containing products within 4 weeks prior to screening.\n* Subject is known to have immune deficiency or is immunocompromised.\n* Subject is ≥ 50 years old AND has a history of heart attack, other clinically significant heart problems, stroke, or blood clots.\n* Subject has a known history of chronic infectious disease (e.g., hepatitis B, hepatitis C, or human immunodeficiency virus \\[HIV\\]).\n* Subject is known to have hepatitis B or hepatitis C viral infection.\n* Subject has used any topical medicated treatment that could affect DLE within 2 weeks prior to Day 1, including, but not limited to, topical corticosteroids, retinoids, calcineurin inhibitors, antimicrobials, and medical devices.\n* Subject has received any marketed or investigational biological agent within 12 weeks or 5 half lives (whichever is longer) prior to Day 1, including but not limited to ustekinumab and rituximab.\n* Subject is currently receiving a nonbiological investigational product or device or has received one within 4 weeks prior to Day 1.\n* Subject has a known or suspected allergy to ruxolitinib.\n* Subject has used ruxolitinib cream (OpzeluraTM).\n* Subject has used JAK inhibitors for conditions other than DLE or other forms of lupus within 4 weeks prior to Day 1.\n* Subject has a known history of clinically significant drug or alcohol abuse in the last year prior to Day 1.","ALL","18 Years",{"count":99,"type":100},20,"ESTIMATED","INTERVENTIONAL",[103],"PHASE2","This study is a single-blind, intraindividual study to evaluate the efficacy of ruxolitinib 1.5 % cream in adult subjects with discoid lupus erythematosus.",[106],"Discoid Lupus Erythematosus",[108,109,110],"discoid lupus erythematosus","opzelura","ruxolitinib cream","2025-03-21",{"date":113,"type":114},"2025-03-24","ACTUAL",{"date":116,"type":114},"2024-04-19",{"date":118,"type":100},"2026-02-28",{"name":5,"class":6},2]