Status:
COMPLETED
Analysis of Non-Invasively Collected Microneedle Device Samples From Mild Plaque Psoriasis for Use in Transcriptomics Profiling
Lead Sponsor:
Janssen Research & Development, LLC
Collaborating Sponsors:
Innovaderm Research Inc.
Conditions:
Psoriasis Vulgaris
Eligibility:
All Genders
18+ years
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 15 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 6 2019
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT03795402
Start Date
March 15 2019
End Date
December 6 2019
Last Update
December 13 2019
Active Locations (1)
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1
Innovaderm Research Inc.
Montreal, Quebec, Canada, H2K 4L5