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

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

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis Vulgaris
• Intervention / Treatment: Device: Microneedle Device

• Study Type: Observational
• Enrollment (Actual): 11

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2K 4L5
      • Innovaderm Research Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Participants with mild chronic plaque psoriasis vulgaris, defined as having a body surface area (BSA) greater than or equal to (>=) 1 percent (%) and less than (<) 10% (excluding palms, soles, face, scalp, and genitals), will be included in this study.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A; 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; Microneedle device will be used for collecting skin samples as a non-invasive method.
Group B; 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; Microneedle device will be used for collecting skin samples as a non-invasive method.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Collaborators: Innovaderm Research Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 15, 2019
• Primary Completion (ACTUAL): November 25, 2019
• Study Completion (ACTUAL): December 6, 2019

Study Registration Dates

• First Submitted: January 4, 2019
• First Submitted That Met QC Criteria: January 4, 2019
• First Posted (ACTUAL): January 7, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 13, 2019
• Last Update Submitted That Met QC Criteria: December 12, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: 8004053 (OTHER: Janssen Research & Development, LLC)

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