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

Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT03795402
Collaborator
Innovaderm Research Inc. (Other)
11
Enrollment
1
Location
8.7
Actual Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Microneedle Device

Study Design

Study Type:
Observational
Actual Enrollment :
11 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
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
Actual Study Start Date :
Mar 15, 2019
Actual Primary Completion Date :
Nov 25, 2019
Actual Study Completion Date :
Dec 6, 2019

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Innovaderm Research Inc. Montreal Quebec Canada H2K 4L5

Sponsors and Collaborators

  • Janssen Research & Development, LLC
  • Innovaderm Research Inc.

Investigators

  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT03795402
Other Study ID Numbers:
  • 8004053
  • 8004053
First Posted:
Jan 7, 2019
Last Update Posted:
Dec 13, 2019
Last Verified:
Dec 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Psoriasis

Study Results

No Results Posted as of Dec 13, 2019