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

NCT ID: NCT03795402

Last Updated: 2019-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-15

Study Completion Date

2019-12-06

Brief Summary

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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.

Detailed Description

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Conditions

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Psoriasis Vulgaris

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Microneedle Device

Intervention Type 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.

Microneedle Device

Intervention Type DEVICE

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

Interventions

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Microneedle Device

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Innovaderm Research Inc.

OTHER

Sponsor Role collaborator

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

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Innovaderm Research Inc.

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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8004053

Identifier Type: OTHER

Identifier Source: secondary_id

8004053

Identifier Type: -

Identifier Source: org_study_id