PsoriasisNCT03048721
Skin Tape Harvesting for Transcriptomics Analysis
A study testing Skin Tape Stripping and Punch Biopsy in people with Psoriasis, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- Skin Tape Stripping and Punch Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2017to 24 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Skin Tape Stripping, Punch Biopsy
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin Tape StrippingProcedure or surgery
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 BiopsyProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| Psoriasis | Experimental | Participants with psoriasis will undergo both skin tape stripping and punch biopsy. Receives: Procedure: Skin Tape Stripping; Procedure: Punch Biopsy |
| Control | Experimental | Participants without psoriasis will undergo both skin tape stripping and punch biopsy. Receives: Procedure: Skin Tape Stripping; Procedure: Punch Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fold Change of Human Beta Defensin2 (hBD2)
Fold Change of Human Beta Defensin2 (hBD2)
Measured: 6 months
Secondary outcomes (2)
Fold Change of T-cell derived IL17A Inflammatory Cytokines
Fold Change of T-cell derived IL17A Inflammatory Cytokines
Measured: 6 months
Fold Change of IFNG Inflammatory Cytokines
Fold Change of IFNG Inflammatory Cytokines
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start14 Aug 2017
- Primary completion24 Sep 2018
- Study completion24 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- AbbVie
- Responsible party
- Principal investigator, Johann E Gudjonsson MD, PhD, University of Michigan
- Investigators
- Johann Gudjonsson, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03048721
- Sponsor's protocol ID
- Derm 684/HUM00115663
- Other IDs
- Derm 684
- Status last verified
- Mar 2020
- First submitted
- 25 Jan 2017
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Tape Harvesting for Transcriptomics Analysis
- ClinicalTrials.gov ID
- NCT03048721
- Acronym / sponsor ID
- Derm 684/HUM00115663
- Conditions
- Psoriasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- AbbVie
- Study start
- 14 Aug 2017 (actual)
- Primary completion
- 24 Sep 2018 (actual)
- Study completion
- 24 Sep 2018 (actual)
- First posted
- 9 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psoriasis | Experimental | Procedure: Skin Tape Stripping, Procedure: Punch BiopsyParticipants with psoriasis will undergo both skin tape stripping and punch biopsy. |
| Control | Experimental | Procedure: Skin Tape Stripping, Procedure: Punch BiopsyParticipants without psoriasis will undergo both skin tape stripping and punch biopsy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin Tape StrippingFor 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. | Procedure or surgery | Control, Psoriasis |
| Punch BiopsyFor 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). | Procedure or surgery | Control, Psoriasis |
Primary outcome
Fold Change of Human Beta Defensin2 (hBD2)
Time frame: 6 months
Fold Change of Human Beta Defensin2 (hBD2)
2 secondary outcomes
Fold Change of T-cell derived IL17A Inflammatory Cytokines
Time frame: 6 months
Fold Change of IFNG Inflammatory Cytokines
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johann Gudjonsson, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin Tape Stripping and Punch Biopsy in people with Psoriasis, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fold Change of Human Beta Defensin2 (hBD2) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020; AzTrials last refreshed its copy on 27 Oct 2026.