Subjects Through the Application of the Mindera Kit Part 2

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

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-01

Study Completion Date

2022-05-30

Brief Summary

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A 16 week study to examine if baseline or on-therapy transcriptomics can be used to help predict selection of medications and provide new therapeutic targets for drug development in psoriasis subjects.

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Detailed Description

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Conditions

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Psoriasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Mindera Kit

The entire duration of the study, including the screening period, will be approximately 16 weeks. Mindera Kit will be applied with applicator and left on the skin for 5 minutes, and once removed, the investigational product (IP) will be placed in a buffer solution, sealed, labeled and sent to Mindera for processing.

Intervention Type OTHER

Other Intervention Names

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MK Patch, Microdermal Patch

Eligibility Criteria

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Inclusion Criteria

1. Subject must have the ability to understand and sign written informed consent.
2. Subject must be an adult male or female adult who is ≥ 18 years of age at the time of screening.
3. Subject must be diagnosed with psoriasis by either a dermatologist or a rheumatologist, with the affected area of ≥ 2 centimeters in diameter.
4. Subjects must be treated with anti-TNF-α (or biosimilar) therapy once enrolled in the study.A two-week period is required to washout of the previous biologic when switching therapies.

Exclusion Criteria

1. Subject is unable or unwilling to give written informed consent and/or to comply with study procedures.
2. Subject has had usage of topical psoriasis treatments on study lesion within 2 weeks prior to baseline studyvisit and unwilling to washout.
3. Subjects currently treated with Hydroxychloroquine (Plaquenil), unless otherwise approved by Sponsor

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No