Psoriasis Vulgaris
Conditions
Brief summary
The purpose of this study is to collect skin biopsies and non-invasive microneedle device samples from participants with mild chronic plaque psoriasis vulgaris to use for transcriptomics profiling for further investigation.
Interventions
DEVICEMicroneedle Device
Microneedle device will be used for collecting skin samples as a non-invasive method.
Sponsors
Innovaderm Research Inc.
Janssen Research & Development, LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant has a history of chronic plaque psoriasis vulgaris for at least 6 months prior to the screening visit * Participant has had stable psoriasis conditions for at least 3 months before screening (information obtained from medical chart or participant's physician, or directly from the participant) * Participant has plaque psoriasis covering \>= 1% but \< 10% of his total BSA on Day 1 * For Group A: Participant has one psoriasis target lesion or individual lesions within the same anatomical region (excluding palms, soles, face, scalp, and genitals), with a target lesion severity score (TLSS) score of \>= 6 on Day 1 allowing the collection of three microneedle device samples and one biopsy sample * For Group B: Participant has one psoriasis target lesion or individual lesions within the same anatomical region (excluding palms, soles, face, scalp, and genitals), with a TLSS score of \>= 6 on Day 1 allowing the collection of one microneedle device sample per visit (replicating the extraction on the same area at each visit) and one biopsy sample
Exclusion criteria
* Participant is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study * Participant has evidence of erythrodermic, pustular, predominantly guttate psoriasis, or drug-induced psoriasis * Participant has a history of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the sample collection or interpretation * Participant is known to have immune deficiency or is immunocompromised * Participant has a history of cancer or lymphoproliferative disease within 5 years prior to Day 1. Participants with successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix are not to be excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of Expression by RNA-sequencing (RNAseq) of Extracted RNA Using Punch Biopsy Method Versus Microneedle Device Sampling Method | Up to 28 days | Measurement of expression by ribonucleic acid (RNA)-sequencing of extracted RNA by the frequently used punch biopsy method and the microneedle device will be performed to have a comparison between both the methods. |
Countries
Canada
Outcome results
None listed