Clinical trial NCT03048721: Skin Tape Harvesting for Transcriptomics Analysis
Official title: Skin Tape Harvesting for Transcriptomics Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: AbbVie
First posted: 2017-02-09
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Transcriptomics is the study of how RNA is expressed under specific conditions. Transcriptomic analyses of lesional skin biopsies can be a useful way to track how a patient responds to a drug and separate out drug responders from non-responders. However, biopsies are painful, carry risk of bleeding infections and scarring. A non-invasive approach, such as tape-harvesting, to obtain transcriptomic data from psoriatic skin would increase our capabilities to monitor patients on treatment and potentially help us predict if the drug will be effective sooner. However, it is not known how well tape-harvesting can capture transcriptomic changes that are occurring in psoriatic skin. The purpose of this study is to address how well tape-harvesting captures the transcriptomic changes that are occurring in psoriatic skin.


Eligibility criteria: Inclusion Criteria:

1. Male or female between ages of 18 to 75 years
2. Psoriasis Group Only: Clinical diagnosis of moderate to severe plaque psoriasis at least 6 months prior to enrollment with a PASI equal to 5 or greater and PGA 3-4;
3. Psoriasis Group Only: Have lesional and non-lesional skin appropriate for biopsy which has not been treated with topical therapies 2 weeks prior to biopsy collection;
4. Psoriasis Group Only: Lesional skin for biopsy must have a Target Lesion Severity Score equal to 6 or greater;
5. Psoriasis Group Only: If subject was on biologic therapy, lesion to be biopsied should have minimal response to therapy;
6. Psoriasis Group Only: Psoriatic plaque lesion for biopsy on skin areas typically affected by psoriasis and representative of overall disease severity;
7. Healthy controls will have neither history of skin diseases nor current evidence of other active inflammatory skin disease.

Exclusion Criteria:

1. Diagnosis of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis.
2. Evidence of skin conditions other than psoriasis that would interfere with the evaluations.
3. Use of systemic anti-psoriasis therapies within 28 days of study initiation, or three times the half-life of the drug, whichever is longer;
4. Use of UVB therapy or moderate strength non-steroidal topical treatments on lesion to be biopsied within 14 days of study initiation;
5. Current enrollment in investigational device or investigational drug trial(s), or receipt of any investigational agent(s) within 28 days before baseline visit;
6. Use of JAK inhibitor within 4 weeks of screening;
7. Known HIV-positive status or known history of any other immuno-suppressing disease;
8. Exposure to hepatitis B or hepatitis C or to high risk factors for hepatitis B or C, such as intravenous drug use in patient;
9. Pregnant or nursing females;
10. Subjects with a history of keloid formation or hypertrophic scarring;
11. Individuals who have lidocaine sensitivity.

Primary outcomes:
measure: Fold Change of Human Beta Defensin2 (hBD2)
timeFrame: 6 months
Secondary outcomes:
measure: Fold Change of T-cell derived IL17A Inflammatory Cytokines
timeFrame: 6 months
measure: Fold Change of IFNG Inflammatory Cytokines
timeFrame: 6 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Johann Gudjonsson, MD
role: PRINCIPAL_INVESTIGATOR
References: