[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620242":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":35,"responsibleParty":55,"collaborators":24,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":24,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":79,"overallStatus":38,"whyStopped":24,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Turn Therapeutics","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"GX-03","EXPERIMENTAL","Treatment Arm",[13],"Combination Product: GX-03",{"label":15,"type":10,"description":16,"interventionNames":17},"Vehicle","Vehicle Control",[18],"Other: Vehicle",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"COMBINATION_PRODUCT","Topical ointment",[9],null,{"type":26,"name":15,"description":27,"armGroupLabels":28,"otherNames":24},"OTHER","Ointment carrier",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":34},"Barry Reece, MS","CONTACT","9728714371","barry.reece@alsglobal.com",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"ALS Global","RECRUITING","Irving","Texas","75062","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-96.94889,32.81402,{"lat":48,"lon":47},[51],{"name":52,"role":32,"phone":53,"phoneExt":24,"email":54},"Jordan Williams","9725732908","jordan.williams@alsglobal.com",{"type":56,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100620242","phase-2-a-double-blind-randomized-vehicle-controlled-phase-2-study-to-assess-the-efficacy-and-safety-of-gx-03-in-adult-subjects-with-moderate-to-severe-atopic-dermatitis-eczema-100620242",false,"NCT07355075","A Double-Blind, Randomized, Vehicle-Controlled Phase 2 Study to Assess the Efficacy and Safety of GX-03 in Adult Subjects With Moderate to Severe Atopic Dermatitis (Eczema)","A Double-Blind, Vehicle-Controlled Study to Assess the Efficacy of GX-03 When Used in a Population of Adult Individuals With Moderate to Severe Eczema","GX-03 in AD","Participants must meet all of the following criteria:\n\n* Adults aged 18 to 80 years, inclusive\n* Male or female subjects in good general health as determined by medical history\n* Presence of visible eczematous skin with disease severity consistent with moderate to severe eczema, as assessed by:\n* Eczema Area and Severity Index (EASI) or Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™)\n* Ability to read, understand, and provide written informed consent in English\n* Willingness and ability to comply with study procedures, including study visits and daily topical application\n* Agreement to use only the assigned study product on designated areas of interest for the duration of the study\n\nExclusion Criteria\n\nIndividuals meeting any of the following criteria will be excluded:\n\n* Pregnant, breastfeeding, or planning pregnancy during the study\n* Presence of any skin condition or dermatologic disease that could interfere with study treatment or assessments\n* Use of systemic or topical immunosuppressive therapies, including corticosteroids, within 3 weeks prior to enrollment\n* Use of anti-inflammatory medications (e.g., topical steroids, ibuprofen, celecoxib); steroid nasal or ophthalmic drops are permitted\n* Use of topical medications at the test sites within 72 hours prior to enrollment\n* Damaged or altered skin at or near test sites (e.g., sunburn, tattoos, scars, uneven pigmentation) that could confound evaluations\n* Any medical condition that, in the investigator's judgment, places the subject at undue risk or compromises study integrity","ALL","18 Years","80 Years",{"count":69,"type":70},110,"ESTIMATED","INTERVENTIONAL",[73],"PHASE2","This is a Phase 2, randomized, double-blind, vehicle-controlled clinical study evaluating the efficacy and safety of GX-03 topical ointment in adult subjects with moderate to severe atopic dermatitis (eczema). The study plans to enroll up to 120 eligible patients with a target of at least 100 completing the study and an ability to expand enrollment up to 200 subjects based on a pre-specified interim assessment conducted by an Independent Data Monitoring Committee (IDMC). Subjects will be randomized in a 1:1 ratio to receive either GX-03 or vehicle control for 8 weeks.\n\nThe study is designed to evaluate improvement in investigator-assessed disease severity, itch, and patient-reported eczema symptoms following topical treatment with GX-03 compared with vehicle control. Efficacy assessments include the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™), Eczema Area and Severity Index (EASI), Peak Pruritus Numeric Rating Scale (PP-NRS), and Patient-Oriented Eczema Measure (POEM).\n\nAn interim assessment of conditional power for the primary efficacy endpoint will occur after the first 50 subjects complete the Week 8 visit or withdraw prematurely. Based on pre-specified criteria defined in the IDMC Charter, the IDMC may recommend continuation as planned, expansion of enrollment up to 200 subjects, or early curtailment of enrollment.",[76,77,78],"Eczema Atopic Dermatitis","Eczema","Atopic Dermatitis",[80,81,77,78],"Moderate-Severe AD","Moderate-Severe Eczema","2026-05-13",{"date":84,"type":85},"2026-05-18","ACTUAL",{"date":87,"type":85},"2025-07-11",{"date":89,"type":70},"2026-07-10",{"name":5,"class":6},1]