[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07352566":3,"trial-entities:NCT07352566":201,"trial-summary:NCT07352566":204},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":142,"secondary_outcomes":150,"sex":154,"minimum_age":155,"maximum_age":17,"healthy_volunteers":156,"eligibility_criteria":157,"std_ages":161,"locations":164,"central_contacts":173,"overall_officials":183,"references":186,"see_also_links":200},"NCT07352566","25-43621","Utilization of a Microdevice for Psoriasis and Atopic Dermatitis","Utilization of a Cutaneous Therapy In Situ Microdevice","NOT_YET_RECRUITING","2030-06-01","2026-06","2026-06-03","2026-08-01","University of California, San Francisco","OTHER",true,"This study is being done to test a microdevice, which is a small device designed to test drugs directly on skin conditions like atopic dermatitis (eczema) and psoriasis.\n\nThe small device, about the size of a grain of rice, has up to 20 tiny reservoirs that hold medications that are approved by the Food and Drug Administration (FDA) for atopic dermatitis and psoriasis. Very small amounts of these medications will be released into the skin (at levels in your body much lower than are typically used). In this study, the device will be tested to see if it's safe and works well for predicting how the skin will react to standard treatments. We will also look at how these reactions are connected to genetic information and overall treatment results.",null,[19,20],"Psoriasis","Atopic Dermatitis",[],"INTERVENTIONAL","DEVICE_FEASIBILITY",[25],"PHASE4",{"count":27,"type":28},10,"ESTIMATED",[30,35,39,43,46,49,52,55,58,61,64,67,70,73,76,79,82,85,88,91,94,97,100,103,106,109,112,115,118,121,124,127,130,133,136,139],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DEVICE","In situ cutaneous microdevice","The small device, about the size of a grain of rice, has up to 20 tiny reservoirs that hold medications that are approved by the Food and Drug Administration (FDA) for atopic dermatitis and psoriasis. In this study, the device will be tested to see if it's safe and works well for predicting how the skin will react to standard treatments. The microdevice will contain a subset of the following: Triamcinolone, 5-fluorouracil, Calcipotriene, Tapinarof, Crisaborole, Tacrolimus, Adalimumab, Etanercept, Certolizumab, Infliximab, Secukinumab, Ixekizumab, Apremilast, Risankizumab, Ustekinumab, Hydroxychloroquine, Methotrexate, Mycophenolate, Azathioprine, Chloroquine, Cyclosporine, Tofacitinib, Deucravacitinib, Dupilumab, Tralokinumab, Guselkumab, Tildrakizumab, Baractinib, Abrocitinib, Upadacitinib, Lebrikizumab, Nemolizumab, Ruxolitinib, Bimekizumab, Roflumilast.",[32],{"type":36,"name":37,"description":37,"armGroupLabels":38},"DRUG","Triamcinolone",[32],{"type":36,"name":40,"description":41,"armGroupLabels":42},"5-Fluorouracil","5-fluorouracil",[32],{"type":36,"name":44,"description":44,"armGroupLabels":45},"Calcipotriene",[32],{"type":36,"name":47,"description":47,"armGroupLabels":48},"Tapinarof",[32],{"type":36,"name":50,"description":50,"armGroupLabels":51},"Crisaborole",[32],{"type":36,"name":53,"description":53,"armGroupLabels":54},"Tacrolimus",[32],{"type":36,"name":56,"description":56,"armGroupLabels":57},"Adalimumab",[32],{"type":36,"name":59,"description":59,"armGroupLabels":60},"Etanercept",[32],{"type":36,"name":62,"description":62,"armGroupLabels":63},"Certolizumab",[32],{"type":36,"name":65,"description":65,"armGroupLabels":66},"Infliximab",[32],{"type":36,"name":68,"description":68,"armGroupLabels":69},"Secukinumab",[32],{"type":36,"name":71,"description":71,"armGroupLabels":72},"Ixekizumab",[32],{"type":36,"name":74,"description":74,"armGroupLabels":75},"Apremilast",[32],{"type":36,"name":77,"description":77,"armGroupLabels":78},"Risankizumab",[32],{"type":36,"name":80,"description":80,"armGroupLabels":81},"Ustekinumab",[32],{"type":36,"name":83,"description":83,"armGroupLabels":84},"Hydroxychloroquine",[32],{"type":36,"name":86,"description":86,"armGroupLabels":87},"Methotrexate",[32],{"type":36,"name":89,"description":89,"armGroupLabels":90},"Mycophenolate",[32],{"type":36,"name":92,"description":92,"armGroupLabels":93},"Azathioprine",[32],{"type":36,"name":95,"description":95,"armGroupLabels":96},"Chloroquine",[32],{"type":36,"name":98,"description":98,"armGroupLabels":99},"Cyclosporine",[32],{"type":36,"name":101,"description":101,"armGroupLabels":102},"Tofacitinib",[32],{"type":36,"name":104,"description":104,"armGroupLabels":105},"Deucravacitinib",[32],{"type":36,"name":107,"description":107,"armGroupLabels":108},"Dupilumab",[32],{"type":36,"name":110,"description":110,"armGroupLabels":111},"Tralokinumab",[32],{"type":36,"name":113,"description":113,"armGroupLabels":114},"Guselkumab",[32],{"type":36,"name":116,"description":116,"armGroupLabels":117},"Tildrakizumab",[32],{"type":36,"name":119,"description":119,"armGroupLabels":120},"Baractinib",[32],{"type":36,"name":122,"description":122,"armGroupLabels":123},"Abrocitinib",[32],{"type":36,"name":125,"description":125,"armGroupLabels":126},"Upadacitinib",[32],{"type":36,"name":128,"description":128,"armGroupLabels":129},"Lebrikizumab",[32],{"type":36,"name":131,"description":131,"armGroupLabels":132},"Nemolizumab",[32],{"type":36,"name":134,"description":134,"armGroupLabels":135},"Ruxolitinib",[32],{"type":36,"name":137,"description":137,"armGroupLabels":138},"Bimekizumab",[32],{"type":36,"name":140,"description":140,"armGroupLabels":141},"Roflumilast",[32],[143,147],{"measure":144,"description":145,"timeFrame":146},"Number of participants with adverse events","The safety of microdevice placement and removal will be based on assessment of adverse events.","1 year",{"measure":148,"description":149,"timeFrame":146},"Proportion of retrieved devices with assessable tissue","The feasibility of microdevice analysis based on the ability to place and retrieve the device with sufficient tissue, of sufficient quality, for downstream histopathology\u002Fmolecular analysis and interpretation of at least 80% of the device reservoirs.",[151],{"measure":152,"description":153,"timeFrame":146},"Change in local skin inflammation (molecular assays)","Feasibility of utilizing quantitative histopathologic assessment and\u002For transcriptional profiling to determine whether there is local change in lesional rash-affected skin with clinically relevant skin inflammation treating agents.","ALL","18 Years",false,{"inclusion":158,"exclusion":159,"raw_text":160},[],[],"Inclusion Criteria:\n\n\\> 18 years of age patients with atopic dermatitis or psoriasis if female patient with child bearing potential (on oral contraceptive pills or intrauterine device for at least 30 days)\n\nExclusion Criteria: None",[162,163],"ADULT","OLDER_ADULT",[165],{"facility":13,"city":166,"state":167,"zip":168,"country":169,"geoPoint":170},"San Francisco","California","94158","United States",{"lat":171,"lon":172},37.77493,-122.41942,[174,179],{"name":175,"role":176,"phone":177,"email":178},"Raymond Cho, MD, PhD","CONTACT","415-353-7800","raymond.cho@ucsf.edu",{"name":180,"role":176,"phone":181,"email":182},"Jeffrey Cheng, MD, PhD","415-575-0524","jeffrey.cheng@ucsf.edu",[184],{"name":175,"affiliation":13,"role":185},"PRINCIPAL_INVESTIGATOR",[187,191,194,197],{"pmid":188,"type":189,"citation":190},"35129472","BACKGROUND","Tsai LL, Phillips WW, Hung YP, Dominas C, Deans K, Ahn S, Ferland B, Weiss K, Lanuti M, Auchincloss H, Schumacher L, Jonas O, Colson YL. First-in-Human Intrathoracic Implantation of Multidrug-Eluting Microdevices for In Situ Chemotherapeutic Sensitivity Testing as Proof of Concept in Nonsmall Cell Lung Cancer. Ann Surg. 2023 May 1;277(5):e1143-e1149. doi: 10.1097\u002FSLA.0000000000005385. Epub 2023 Apr 6.",{"pmid":192,"type":189,"citation":193},"35788566","Tatarova Z, Blumberg DC, Korkola JE, Heiser LM, Muschler JL, Schedin PJ, Ahn SW, Mills GB, Coussens LM, Jonas O, Gray JW. A multiplex implantable microdevice assay identifies synergistic combinations of cancer immunotherapies and conventional drugs. Nat Biotechnol. 2022 Dec;40(12):1823-1833. doi: 10.1038\u002Fs41587-022-01379-y. Epub 2022 Jul 4.",{"pmid":195,"type":189,"citation":196},"37672566","Peruzzi P, Dominas C, Fell G, Bernstock JD, Blitz S, Mazzetti D, Zdioruk M, Dawood HY, Triggs DV, Ahn SW, Bhagavatula SK, Davidson SM, Tatarova Z, Pannell M, Truman K, Ball A, Gold MP, Pister V, Fraenkel E, Chiocca EA, Ligon KL, Wen PY, Jonas O. Intratumoral drug-releasing microdevices allow in situ high-throughput pharmaco phenotyping in patients with gliomas. Sci Transl Med. 2023 Sep 6;15(712):eadi0069. doi: 10.1126\u002Fscitranslmed.adi0069. Epub 2023 Sep 6.",{"pmid":198,"type":189,"citation":199},"25904741","Jonas O, Landry HM, Fuller JE, Santini JT Jr, Baselga J, Tepper RI, Cima MJ, Langer R. An implantable microdevice to perform high-throughput in vivo drug sensitivity testing in tumors. Sci Transl Med. 2015 Apr 22;7(284):284ra57. doi: 10.1126\u002Fscitranslmed.3010564.",[],{"nct_id":4,"conditions":202,"biomarkers":203},[20,19],[],{"nct_id":4,"found":15,"summary":205,"prompt_version":215},{"design":206,"status":207,"heading":208,"summary":209,"follow_up":210,"word_count":211,"commitments":212,"compensation":213,"drugs_mentioned":214},"This interventional study plans to enroll 10 participants to test a microdevice directly on the skin.","completed","Microdevice for Psoriasis and Atopic Dermatitis","This study is testing a small device, about the size of a grain of rice, for people with atopic dermatitis (eczema) or psoriasis. This microdevice holds tiny amounts of FDA-approved medications like Triamcinolone, 5-Fluorouracil, Calcipotriene, and Tapinarof. These medications will be released directly into your skin at very low levels. The goal is to see if the device is safe and can help predict how your skin will react to standard treatments. We'll also look at how these reactions relate to your genetic information and overall treatment results. The study aims to enroll 10 participants and is currently unclear on its recruitment status.","Participants will be followed for adverse events and device assessment for up to 1 year.",103,"Not specified in the trial record.","Not stated in the trial record.",[37,40,44,47],"v2"]