NCT03795402

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 7, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

March 15, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2019

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2019

Completed
Last Updated

December 13, 2019

Status Verified

December 1, 2019

Enrollment Period

9 months

First QC Date

January 4, 2019

Last Update Submit

December 12, 2019

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

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

Interventions

Microneedle DeviceDEVICE

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

Group AGroup B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Innovaderm Research Inc.

Montreal, Quebec, H2K 4L5, Canada

Location

Study Officials

  • Janssen Research & Development, LLC Clinical Trial

    Janssen Research & Development, LLC

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2019

First Posted

January 7, 2019

Study Start

March 15, 2019

Primary Completion

November 25, 2019

Study Completion

December 6, 2019

Last Updated

December 13, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)