Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:59 AM
Study NCT ID:
NCT07352566
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-20
First Post:
2025-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Utilization of a Microdevice for Psoriasis and Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D003876', 'term': 'Dermatitis, Atopic'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014221', 'term': 'Triamcinolone'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'C055085', 'term': 'calcipotriene'}, {'id': 'C571829', 'term': 'tapinarof'}, {'id': 'C543085', 'term': 'crisaborole'}, {'id': 'D016559', 'term': 'Tacrolimus'}, {'id': 'D000068879', 'term': 'Adalimumab'}, {'id': 'D000068800', 'term': 'Etanercept'}, {'id': 'D000068582', 'term': 'Certolizumab Pegol'}, {'id': 'D000069285', 'term': 'Infliximab'}, {'id': 'C555450', 'term': 'secukinumab'}, {'id': 'C549079', 'term': 'ixekizumab'}, {'id': 'C505730', 'term': 'apremilast'}, {'id': 'C000601773', 'term': 'risankizumab'}, {'id': 'D000069549', 'term': 'Ustekinumab'}, {'id': 'D006886', 'term': 'Hydroxychloroquine'}, {'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'D009173', 'term': 'Mycophenolic Acid'}, {'id': 'D001379', 'term': 'Azathioprine'}, {'id': 'D002738', 'term': 'Chloroquine'}, {'id': 'D016572', 'term': 'Cyclosporine'}, {'id': 'C479163', 'term': 'tofacitinib'}, {'id': 'C000628674', 'term': 'deucravacitinib'}, {'id': 'C582203', 'term': 'dupilumab'}, {'id': 'C574065', 'term': 'tralokinumab'}, {'id': 'C000588857', 'term': 'guselkumab'}, {'id': 'C000598434', 'term': 'tildrakizumab'}, {'id': 'C000634427', 'term': 'abrocitinib'}, {'id': 'C000613732', 'term': 'upadacitinib'}, {'id': 'C561806', 'term': 'lebrikizumab'}, {'id': 'C000612881', 'term': 'nemolizumab'}, {'id': 'C540383', 'term': 'ruxolitinib'}, {'id': 'C000625981', 'term': 'bimekizumab'}, {'id': 'C424423', 'term': 'Roflumilast'}], 'ancestors': [{'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D007141', 'term': 'Immunoglobulin Fc Fragments'}, {'id': 'D007128', 'term': 'Immunoglobulin Fragments'}, {'id': 'D010446', 'term': 'Peptide Fragments'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D007127', 'term': 'Immunoglobulin Constant Regions'}, {'id': 'D018124', 'term': 'Receptors, Tumor Necrosis Factor'}, {'id': 'D018121', 'term': 'Receptors, Cytokine'}, {'id': 'D011971', 'term': 'Receptors, Immunologic'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D011092', 'term': 'Polyethylene Glycols'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D007140', 'term': 'Immunoglobulin Fab Fragments'}, {'id': 'D000634', 'term': 'Aminoquinolines'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D013872', 'term': 'Thionucleosides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D015122', 'term': 'Mercaptopurine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-11-11', 'size': 1230875, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2026-01-13T16:55', 'hasProtocol': True}, {'date': '2025-11-11', 'size': 91329, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-12-15T15:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2030-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-13', 'studyFirstSubmitDate': '2025-11-17', 'studyFirstSubmitQcDate': '2026-01-13', 'lastUpdatePostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with adverse events', 'timeFrame': '1 year', 'description': 'The safety of microdevice placement and removal will be based on assessment of adverse events.'}, {'measure': 'Proportion of retrieved devices with assessable tissue', 'timeFrame': '1 year', 'description': 'The feasibility of microdevice analysis based on the ability to place and retrieve the device with sufficient tissue, of sufficient quality, for downstream histopathology/molecular analysis and interpretation of at least 80% of the device reservoirs.'}], 'secondaryOutcomes': [{'measure': 'Change in local skin inflammation (molecular assays)', 'timeFrame': '1 year', 'description': 'Feasibility of utilizing quantitative histopathologic assessment and/or transcriptional profiling to determine whether there is local change in lesional rash-affected skin with clinically relevant skin inflammation treating agents.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psoriasis', 'Atopic Dermatitis']}, 'referencesModule': {'references': [{'pmid': '35129472', 'type': 'BACKGROUND', 'citation': '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/SLA.0000000000005385. Epub 2023 Apr 6.'}, {'pmid': '35788566', 'type': 'BACKGROUND', 'citation': '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/s41587-022-01379-y. Epub 2022 Jul 4.'}, {'pmid': '37672566', 'type': 'BACKGROUND', 'citation': '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/scitranslmed.adi0069. Epub 2023 Sep 6.'}, {'pmid': '25904741', 'type': 'BACKGROUND', 'citation': '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/scitranslmed.3010564. Erratum In: Sci Transl Med. 2019 Nov 27;11(520):eaba1552. doi: 10.1126/scitranslmed.aba1552.'}]}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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'}, 'identificationModule': {'nctId': 'NCT07352566', 'briefTitle': 'Utilization of a Microdevice for Psoriasis and Atopic Dermatitis', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Utilization of a Cutaneous Therapy In Situ Microdevice', 'orgStudyIdInfo': {'id': '25-43621'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'In situ cutaneous microdevice', 'description': "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. 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.", 'interventionNames': ['Device: In situ cutaneous microdevice', 'Drug: Triamcinolone', 'Drug: 5-Fluorouracil', 'Drug: Calcipotriene', 'Drug: Tapinarof', 'Drug: Crisaborole', 'Drug: Tacrolimus', 'Drug: Adalimumab', 'Drug: Etanercept', 'Drug: Certolizumab', 'Drug: Infliximab', 'Drug: Secukinumab', 'Drug: Ixekizumab', 'Drug: Apremilast', 'Drug: Risankizumab', 'Drug: Ustekinumab', 'Drug: Hydroxychloroquine', 'Drug: Methotrexate', 'Drug: Mycophenolate', 'Drug: Azathioprine', 'Drug: Chloroquine', 'Drug: Cyclosporine', 'Drug: Tofacitinib', 'Drug: Deucravacitinib', 'Drug: Dupilumab', 'Drug: Tralokinumab', 'Drug: Guselkumab', 'Drug: Tildrakizumab', 'Drug: Baractinib', 'Drug: Abrocitinib', 'Drug: Upadacitinib', 'Drug: Lebrikizumab', 'Drug: Nemolizumab', 'Drug: Ruxolitinib', 'Drug: Bimekizumab', 'Drug: Roflumilast']}], 'interventions': [{'name': 'In situ cutaneous microdevice', 'type': 'DEVICE', 'description': "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.", 'armGroupLabels': ['In situ cutaneous microdevice']}, {'name': 'Triamcinolone', 'type': 'DRUG', 'description': 'Triamcinolone', 'armGroupLabels': ['In situ cutaneous microdevice']}, {'name': '5-Fluorouracil', 'type': 'DRUG', 'description': '5-fluorouracil', 'armGroupLabels': ['In situ cutaneous microdevice']}, {'name': 'Calcipotriene', 'type': 'DRUG', 'description': 'Calcipotriene', 'armGroupLabels': ['In situ cutaneous microdevice']}, {'name': 'Tapinarof', 'type': 'DRUG', 'description': 'Tapinarof', 'armGroupLabels': ['In situ cutaneous microdevice']}, {'name': 'Crisaborole', 'type': 'DRUG', 'description': 'Crisaborole', 'armGroupLabels': ['In situ cutaneous microdevice']}, {'name': 'Tacrolimus', 'type': 'DRUG', 'description': 'Tacrolimus', 'armGroupLabels': ['In situ cutaneous microdevice']}, {'name': 'Adalimumab', 'type': 'DRUG', 'description': 'Adalimumab', 'armGroupLabels': ['In situ cutaneous microdevice']}, {'name': 'Etanercept', 'type': 'DRUG', 'description': 'Etanercept', 'armGroupLabels': ['In situ cutaneous microdevice']}, {'name': 'Certolizumab', 'type': 'DRUG', 'description': 'Certolizumab', 'armGroupLabels': ['In situ cutaneous microdevice']}, {'name': 'Infliximab', 'type': 'DRUG', 'description': 'Infliximab', 'armGroupLabels': ['In situ cutaneous microdevice']}, {'name': 'Secukinumab', 'type': 'DRUG', 'description': 'Secukinumab', 'armGroupLabels': ['In situ cutaneous microdevice']}, {'name': 'Ixekizumab', 'type': 'DRUG', 'description': 'Ixekizumab', 'armGroupLabels': ['In situ cutaneous microdevice']}, {'name': 'Apremilast', 'type': 'DRUG', 'description': 'Apremilast', 'armGroupLabels': ['In situ cutaneous microdevice']}, {'name': 'Risankizumab', 'type': 'DRUG', 'description': 'Risankizumab', 'armGroupLabels': ['In situ cutaneous microdevice']}, {'name': 'Ustekinumab', 'type': 'DRUG', 'description': 'Ustekinumab', 'armGroupLabels': ['In situ cutaneous microdevice']}, {'name': 'Hydroxychloroquine', 'type': 'DRUG', 'description': 'Hydroxychloroquine', 'armGroupLabels': ['In situ cutaneous microdevice']}, {'name': 'Methotrexate', 'type': 'DRUG', 'description': 'Methotrexate', 'armGroupLabels': ['In situ cutaneous microdevice']}, {'name': 'Mycophenolate', 'type': 'DRUG', 'description': 'Mycophenolate', 'armGroupLabels': ['In situ cutaneous microdevice']}, {'name': 'Azathioprine', 'type': 'DRUG', 'description': 'Azathioprine', 'armGroupLabels': ['In situ cutaneous microdevice']}, {'name': 'Chloroquine', 'type': 'DRUG', 'description': 'Chloroquine', 'armGroupLabels': ['In situ cutaneous microdevice']}, {'name': 'Cyclosporine', 'type': 'DRUG', 'description': 'Cyclosporine', 'armGroupLabels': ['In situ cutaneous microdevice']}, {'name': 'Tofacitinib', 'type': 'DRUG', 'description': 'Tofacitinib', 'armGroupLabels': ['In situ cutaneous microdevice']}, {'name': 'Deucravacitinib', 'type': 'DRUG', 'description': 'Deucravacitinib', 'armGroupLabels': ['In situ cutaneous microdevice']}, {'name': 'Dupilumab', 'type': 'DRUG', 'description': 'Dupilumab', 'armGroupLabels': ['In situ cutaneous microdevice']}, {'name': 'Tralokinumab', 'type': 'DRUG', 'description': 'Tralokinumab', 'armGroupLabels': ['In situ cutaneous microdevice']}, {'name': 'Guselkumab', 'type': 'DRUG', 'description': 'Guselkumab', 'armGroupLabels': ['In situ cutaneous microdevice']}, {'name': 'Tildrakizumab', 'type': 'DRUG', 'description': 'Tildrakizumab', 'armGroupLabels': ['In situ cutaneous microdevice']}, {'name': 'Baractinib', 'type': 'DRUG', 'description': 'Baractinib', 'armGroupLabels': ['In situ cutaneous microdevice']}, {'name': 'Abrocitinib', 'type': 'DRUG', 'description': 'Abrocitinib', 'armGroupLabels': ['In situ cutaneous microdevice']}, {'name': 'Upadacitinib', 'type': 'DRUG', 'description': 'Upadacitinib', 'armGroupLabels': ['In situ cutaneous microdevice']}, {'name': 'Lebrikizumab', 'type': 'DRUG', 'description': 'Lebrikizumab', 'armGroupLabels': ['In situ cutaneous microdevice']}, {'name': 'Nemolizumab', 'type': 'DRUG', 'description': 'Nemolizumab', 'armGroupLabels': ['In situ cutaneous microdevice']}, {'name': 'Ruxolitinib', 'type': 'DRUG', 'description': 'Ruxolitinib', 'armGroupLabels': ['In situ cutaneous microdevice']}, {'name': 'Bimekizumab', 'type': 'DRUG', 'description': 'Bimekizumab', 'armGroupLabels': ['In situ cutaneous microdevice']}, {'name': 'Roflumilast', 'type': 'DRUG', 'description': 'Roflumilast', 'armGroupLabels': ['In situ cutaneous microdevice']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'centralContacts': [{'name': 'Raymond Cho, MD, PhD', 'role': 'CONTACT', 'email': 'raymond.cho@ucsf.edu', 'phone': '415-353-7800'}, {'name': 'Jeffrey Cheng, MD, PhD', 'role': 'CONTACT', 'email': 'jeffrey.cheng@ucsf.edu', 'phone': '415-575-0524'}], 'overallOfficials': [{'name': 'Raymond Cho, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}