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

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Psoriasis Vulgaris

Treatments: Device: Microneedle Device

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03795402

8004053 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

11 participants in 2 patient groups

Group A

Description:

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.

Treatment:

Device: Microneedle Device

Group B

Description:

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.

Treatment:

Device: Microneedle Device