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

Psoriasis Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03795402
• Other study ID #: 8004053
• Secondary ID: 8004053
• Status: Completed
• Start date: March 15, 2019
• Est. completion date: December 6, 2019

Study information

• Verified date: December 2019
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: December 6, 2019
• Est. primary completion date: November 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

Device:
• Microneedle Device
Microneedle device will be used for collecting skin samples as a non-invasive method.

Locations

Country	Name	City	State
Canada	Innovaderm Research Inc.	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC	Innovaderm Research Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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