Utilization of a Microdevice for Psoriasis and Atopic Dermatitis

Utilization of a Cutaneous Therapy In Situ Microdevice

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Psoriasis; Atopic Dermatitis
• Intervention / Treatment: Drug: Methotrexate; Drug: Hydroxychloroquine; Drug: Nemolizumab; Drug: Adalimumab; Drug: Infliximab; Drug: Guselkumab; Drug: Apremilast; Drug: Cyclosporine; Drug: Roflumilast; Drug: Etanercept; Drug: Tacrolimus; Drug: Ruxolitinib; Drug: Azathioprine; Drug: Triamcinolone; Drug: Risankizumab; Device: In situ cutaneous microdevice; Drug: 5-Fluorouracil; Drug: Calcipotriene; Drug: Tapinarof; Drug: Crisaborole; Drug: Certolizumab; Drug: Secukinumab; Drug: Ixekizumab; Drug: Ustekinumab; Drug: Mycophenolate; Drug: Chloroquine; Drug: Tofacitinib; Drug: Deucravacitinib; Drug: Dupilumab; Drug: Tralokinumab; Drug: Tildrakizumab; Drug: Baractinib; Drug: Abrocitinib; Drug: Upadacitinib; Drug: Lebrikizumab; Drug: Bimekizumab

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Raymond Cho, MD, PhD; Phone Number: 415-353-7800; Email: raymond.cho@ucsf.edu
• Study Contact Backup: Name: Jeffrey Cheng, MD, PhD; Phone Number: 415-575-0524; Email: jeffrey.cheng@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94158
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

> 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)

Exclusion Criteria: None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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. 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.

Drug: Methotrexate; Methotrexate; Drug: Hydroxychloroquine; Hydroxychloroquine; Drug: Nemolizumab; Nemolizumab; Drug: Adalimumab; Adalimumab; Drug: Infliximab; Infliximab; Drug: Guselkumab; Guselkumab; Drug: Apremilast; Apremilast; Drug: Cyclosporine; Cyclosporine; Drug: Roflumilast; Roflumilast; Drug: Etanercept; Etanercept; Drug: Tacrolimus; Tacrolimus; Drug: Ruxolitinib; Ruxolitinib; Drug: Azathioprine; Azathioprine; Drug: Triamcinolone; Triamcinolone; Drug: Risankizumab; Risankizumab; 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.; Drug: 5-Fluorouracil; 5-fluorouracil; Drug: Calcipotriene; Calcipotriene; Drug: Tapinarof; Tapinarof; Drug: Crisaborole; Crisaborole; Drug: Certolizumab; Certolizumab; Drug: Secukinumab; Secukinumab; Drug: Ixekizumab; Ixekizumab; Drug: Ustekinumab; Ustekinumab; Drug: Mycophenolate; Mycophenolate; Drug: Chloroquine; Chloroquine; Drug: Tofacitinib; Tofacitinib; Drug: Deucravacitinib; Deucravacitinib; Drug: Dupilumab; Dupilumab; Drug: Tralokinumab; Tralokinumab; Drug: Tildrakizumab; Tildrakizumab; Drug: Baractinib; Baractinib; Drug: Abrocitinib; Abrocitinib; Drug: Upadacitinib; Upadacitinib; Drug: Lebrikizumab; Lebrikizumab; Drug: Bimekizumab; Bimekizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events	The safety of microdevice placement and removal will be based on assessment of adverse events.	1 year
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/molecular analysis and interpretation of at least 80% of the device reservoirs.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in local skin inflammation (molecular assays)	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.	1 year

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Raymond Cho, MD, PhD, University of California, San Francisco

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2030

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: January 13, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases, Papulosquamous; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Psoriasis; Dermatitis, Atopic; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Fatty Acids; Lipids; Nucleic Acids, Nucleotides, and Nucleosides; Acids, Acyclic; Carboxylic Acids; Polycyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Purines; Pyrimidines; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Polymers; Macromolecular Substances; Macrolides; Lactones; Receptors, Cell Surface; Membrane Proteins; Nucleosides; Pterins; Pteridines; Uracil; Pyrimidinones; Aminopterin; Macrocyclic Compounds; Quinolines; Peptides, Cyclic; Aminoquinolines; Caproates; Cyclosporins; Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Immunoglobulin Constant Regions; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Thionucleosides; Mercaptopurine; Polyethylene Glycols; Immunoglobulin Fab Fragments; Etanercept; Adalimumab; Infliximab; Certolizumab Pegol; Ustekinumab; Methotrexate; Fluorouracil; Hydroxychloroquine; Mycophenolic Acid; Tacrolimus; Cyclosporine; Azathioprine; Triamcinolone; Chloroquine; guselkumab; upadacitinib; lebrikizumab; risankizumab; ixekizumab; ruxolitinib; dupilumab; deucravacitinib; tofacitinib; tralokinumab; bimekizumab; abrocitinib; secukinumab; apremilast; tildrakizumab; calcipotriene; Roflumilast; nemolizumab; tapinarof; crisaborole
• Other Study ID Numbers: 25-43621

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No