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

Study Purpose

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 Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

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Study Type
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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 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

Trial Details

This trial id was obtained from, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.


The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Janssen Research & Development, LLC

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Janssen Research & Development, LLC Clinical Trial
Principal Investigator Affiliation Janssen Research & Development, LLC

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Overall Status Recruiting
Countries Canada

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis Vulgaris

Contact a Trial Team

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International Sites

Innovaderm Research Inc., Montreal, Quebec, Canada




Innovaderm Research Inc.

Montreal, Quebec, H2K 4L5

Nearest Location

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