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

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ClinicalTrials.gov Identifier: NCT03795402
Recruitment Status : Recruiting
First Posted : January 7, 2019
Last Update Posted : March 21, 2019
Sponsor:
Collaborator:
Innovaderm Research Inc.
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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.

Condition or disease Intervention/treatment
Psoriasis Vulgaris Device: Microneedle Device

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Study Type : Observational
Estimated Enrollment : 11 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : March 15, 2019
Estimated Primary Completion Date : June 3, 2019
Estimated Study Completion Date : June 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Psoriasis

Group/Cohort Intervention/treatment
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
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.
Device: Microneedle Device
Microneedle device will be used for collecting skin samples as a non-invasive method.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability 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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03795402


Contacts
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Contact: Valerie Berbin 514-521-4285 vbarbin@innovaderm.ca

Locations
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Canada, Quebec
Innovaderm Research Inc. Recruiting
Montreal, Quebec, Canada, H2K 4L5
Sponsors and Collaborators
Janssen Research & Development, LLC
Innovaderm Research Inc.
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03795402     History of Changes
Other Study ID Numbers: 8004053
8004053 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: January 7, 2019    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases