Psoriasis, Atopic Dermatitis
Conditions
Brief summary
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.
Interventions
DEVICEIn 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.
DRUGTriamcinolone
Triamcinolone
DRUG5-Fluorouracil
5-fluorouracil
DRUGCalcipotriene
Calcipotriene
DRUGTapinarof
Tapinarof
DRUGCrisaborole
Crisaborole
DRUGTacrolimus
Tacrolimus
DRUGAdalimumab
Adalimumab
DRUGEtanercept
Etanercept
DRUGCertolizumab
Certolizumab
DRUGInfliximab
Infliximab
DRUGSecukinumab
Secukinumab
DRUGIxekizumab
Ixekizumab
DRUGApremilast
Apremilast
DRUGRisankizumab
Risankizumab
DRUGUstekinumab
Ustekinumab
DRUGHydroxychloroquine
Hydroxychloroquine
DRUGMethotrexate
Methotrexate
DRUGMycophenolate
Mycophenolate
DRUGAzathioprine
Azathioprine
DRUGChloroquine
Chloroquine
DRUGCyclosporine
Cyclosporine
DRUGTofacitinib
Tofacitinib
DRUGDeucravacitinib
Deucravacitinib
DRUGDupilumab
Dupilumab
DRUGTralokinumab
Tralokinumab
DRUGGuselkumab
Guselkumab
DRUGTildrakizumab
Tildrakizumab
DRUGBaractinib
Baractinib
DRUGAbrocitinib
Abrocitinib
DRUGUpadacitinib
Upadacitinib
DRUGLebrikizumab
Lebrikizumab
DRUGNemolizumab
Nemolizumab
DRUGRuxolitinib
Ruxolitinib
DRUGBimekizumab
Bimekizumab
DRUGRoflumilast
Roflumilast
Sponsors
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events | 1 year | The safety of microdevice placement and removal will be based on assessment of adverse events. |
| Proportion of retrieved devices with assessable tissue | 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in local skin inflammation (molecular assays) | 1 year | 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. |
Countries
United States
Contacts
CONTACTRaymond Cho, MD, PhD
CONTACTJeffrey Cheng, MD, PhD
PRINCIPAL_INVESTIGATORRaymond Cho, MD, PhD
University of California, San Francisco
Outcome results
None listed