Skin Tape Harvesting for Transcriptomics Analysis

NCT ID: NCT03048721

Last Updated: 2020-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-14
• Study Completion Date: 2018-09-24

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.

Conditions

Psoriasis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Psoriasis

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

Group Type: EXPERIMENTAL

Skin Tape Stripping

Intervention Type: PROCEDURE

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.

Punch Biopsy

Intervention Type: PROCEDURE

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).

Control

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

Group Type: EXPERIMENTAL

Skin Tape Stripping

Intervention Type: PROCEDURE

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.

Punch Biopsy

Intervention Type: PROCEDURE

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).

Interventions

Skin Tape Stripping

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

Punch Biopsy

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).

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AbbVie

INDUSTRY

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Johann E Gudjonsson MD, PhD

Associate Professor Dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Johann Gudjonsson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

Derm 684

Identifier Type: OTHER

Identifier Source: secondary_id

Derm 684/HUM00115663

Identifier Type: -

Identifier Source: org_study_id