Analysis of Non-Invasively Collected Microneedle Device Samples From Mild Plaque Psoriasis for Use in Transcriptomics Profiling

Study Overview
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Brief Summary
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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.

Official Title
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Collection of Skin Punch Biopsies and Non-Invasively Collected Microneedle Device Samples From Subjects With Mild Chronic Plaque Psoriasis Vulgaris to Use for Transcriptomics Profiling

Conditions
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Psoriasis Vulgaris

Intervention / Treatment
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* Device: Microneedle Device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A<br>Three microneedle device samples will be collected from a psoriasis lesion and from nonlesional (healthy) skin on Day 1. Two skin biopsies of 4 millimeter (mm) will be performed on Day 1. No investigational drug product will be administered during this study. | Device: Microneedle Device<br>* Microneedle device will be used for collecting skin samples as a non-invasive method.<br>|
| Group B<br>One microneedle device sample will be collected from a psoriasis lesion and from nonlesional (healthy) skin on Day 1 and at Weeks 2 and 4. Two skin biopsies of 4 mm will be performed on Day 1. No investigational drug product will be administered during this study. | Device: Microneedle Device<br>* Microneedle device will be used for collecting skin samples as a non-invasive method.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of Expression by RNA-sequencing (RNAseq) of Extracted RNA Using Punch Biopsy Method Versus Microneedle Device Sampling Method | 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. | Up to 28 days |