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

Janssen Research & Development, LLC1 site in 1 country11 target enrollmentMarch 15, 2019

ConditionsPsoriasis Vulgaris

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Psoriasis Vulgaris
Sponsor: Janssen Research & Development, LLC
Enrollment: 11
Locations: 1
Primary Endpoint: Measurement of Expression by RNA-sequencing (RNAseq) of Extracted RNA Using Punch Biopsy Method Versus Microneedle Device Sampling Method
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 15, 2019

End Date

December 6, 2019

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Janssen Research & Development, LLC

Responsible Party

Sponsor

Eligibility Criteria

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
•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

Outcomes

Primary Outcomes

Measurement of Expression by RNA-sequencing (RNAseq) of Extracted RNA Using Punch Biopsy Method Versus Microneedle Device Sampling Method

Time Frame: 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.