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Skin Tape Harvesting for Transcriptomics Analysis

Primary Purpose

Psoriasis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Skin Tape Stripping

Punch Biopsy

About this trial

This is an interventional other trial for Psoriasis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Male or female between ages of 18 to 75 years
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;
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;
Psoriasis Group Only: Lesional skin for biopsy must have a Target Lesion Severity Score equal to 6 or greater;
Psoriasis Group Only: If subject was on biologic therapy, lesion to be biopsied should have minimal response to therapy;
Psoriasis Group Only: Psoriatic plaque lesion for biopsy on skin areas typically affected by psoriasis and representative of overall disease severity;
Healthy controls will have neither history of skin diseases nor current evidence of other active inflammatory skin disease.

Exclusion Criteria:

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

Sites / Locations

University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Psoriasis

Control

Arm Description

Participants with psoriasis will undergo both skin tape stripping and punch biopsy.

Participants without psoriasis will undergo both skin tape stripping and punch biopsy.

Outcomes

Primary Outcome Measures

Fold Change of Human Beta Defensin2 (hBD2)

Secondary Outcome Measures

Fold Change of T-cell derived IL17A Inflammatory Cytokines

Fold Change of IFNG Inflammatory Cytokines

Full Information

NCT ID

NCT03048721

First Posted

January 25, 2017

Last Updated

March 2, 2020

Sponsor

University of Michigan

Collaborators

AbbVie

1. Study Identification

Unique Protocol Identification Number

NCT03048721

Brief Title

Skin Tape Harvesting for Transcriptomics Analysis

Official Title

Skin Tape Harvesting for Transcriptomics Analysis

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

August 14, 2017 (Actual)

Primary Completion Date

September 24, 2018 (Actual)

Study Completion Date

September 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

Collaborators

AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Psoriasis

Arm Type

Experimental

Arm Description

Participants with psoriasis will undergo both skin tape stripping and punch biopsy.

Arm Title

Control

Arm Type

Experimental

Arm Description

Participants without psoriasis will undergo both skin tape stripping and punch biopsy.

Intervention Type

Procedure

Intervention Name(s)

Skin Tape Stripping

Intervention Description

For psoriasis group, tape-stripping will be done in both involved and uninvolved skin. The tape-stripping will be performed within 2.5 cm of the first punch biopsy. For healthy control group, tape-stripping will be performed on normal skin, within 2.5. cm of the first punch biopsy.

Intervention Type

Procedure

Intervention Name(s)

Punch Biopsy

Intervention Description

For psoriasis group, one punch biopsy will be taken from each of the following areas: involved skin, tape-stripped involved skin, uninvolved skin, and tape-stripped uninvolved skin. For healthy control group, one punch biopsy will be taken from each of the following areas: normal skin and tape-stripped normal skin (within 2.5 cm of the first punch biopsy).

Primary Outcome Measure Information:

Title

Fold Change of Human Beta Defensin2 (hBD2)

Description

Fold Change of Human Beta Defensin2 (hBD2)

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Fold Change of T-cell derived IL17A Inflammatory Cytokines

Description

Fold Change of T-cell derived IL17A Inflammatory Cytokines

Time Frame

6 months

Title

Fold Change of IFNG Inflammatory Cytokines

Description

Fold Change of IFNG Inflammatory Cytokines

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female between ages of 18 to 75 years 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; 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; Psoriasis Group Only: Lesional skin for biopsy must have a Target Lesion Severity Score equal to 6 or greater; Psoriasis Group Only: If subject was on biologic therapy, lesion to be biopsied should have minimal response to therapy; Psoriasis Group Only: Psoriatic plaque lesion for biopsy on skin areas typically affected by psoriasis and representative of overall disease severity; Healthy controls will have neither history of skin diseases nor current evidence of other active inflammatory skin disease. Exclusion Criteria: Diagnosis of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis. Evidence of skin conditions other than psoriasis that would interfere with the evaluations. Use of systemic anti-psoriasis therapies within 28 days of study initiation, or three times the half-life of the drug, whichever is longer; Use of UVB therapy or moderate strength non-steroidal topical treatments on lesion to be biopsied within 14 days of study initiation; Current enrollment in investigational device or investigational drug trial(s), or receipt of any investigational agent(s) within 28 days before baseline visit; Use of JAK inhibitor within 4 weeks of screening; Known HIV-positive status or known history of any other immuno-suppressing disease; Exposure to hepatitis B or hepatitis C or to high risk factors for hepatitis B or C, such as intravenous drug use in patient; Pregnant or nursing females; Subjects with a history of keloid formation or hypertrophic scarring; Individuals who have lidocaine sensitivity.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Johann Gudjonsson, MD

Organizational Affiliation

University of Michigan

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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