HealthyNCT04537468
Development of a Method to Measure mRNA Levels in Skin Samples
A study testing Skin squame collection, Tape strip collection and Tape strip and skin biopsy collection in people with Healthy and Atopic Dermatitis Eczema, run by Innovaderm Research Inc. at 1 site in Canada.
Trial summary
The purpose of this study was to develop a non-invasive method to measure mRNA levels using tape stripping on the skin of patients with psoriasis and patients with atopic dermatitis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Atopic Dermatitis Eczema, Psoriasis
- What is being tested?
- Skin squame collection, Tape strip collection and Tape strip and skin biopsy collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteCanada
- Study dates
- 11 May 2017to 2 Oct 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject, male or female, aged 18 years or older at the time of consent.
- Female subjects of childbearing potential had a negative urine pregnancy test at the screening visit.
- Subjects had to be able and willing to provide written informed consent and comply with the requirements of the study protocol. Consent was obtained prior to any study-related procedures.
- Special inclusion criteria for volunteers with atopic dermatitis or psoriasis:
- Patient had a history of atopic dermatitis or psoriasis.
- Patient with psoriasis had a Physician's Global Assessment (PGA) score of ≥2 at Day 0.
- Patients with atopic dermatitis had an Investigator's Global Assessment (IGA) score of ≥2 at Day 0.
Who cannot join
- Female subject was pregnant or breastfeeding.
- Subject was participating in a clinical trial with an experimental drug or device or had participated in a clinical trial with an experimental drug or device within the last 4 weeks of the collection day (Day 0).
- Subject was known to have hepatitis B or hepatitis C viral infection.
- Subject was known to have immune deficiency or was immunocompromised.
- Subject had used systemic medication, medical devices, UVB or PUVA therapy or natural health products to treat atopic dermatitis or psoriasis on the areas to be biopsied or tape stripped within 4 weeks of the collection day (Day 0).
- Subject had used oral, intravenous steroids, or immunosuppressive medication within 4 weeks of the collection day (Day 0). Subject had used intramuscular or intra-lesional or intra-articular steroids or immunosuppressive medication on the areas to be biopsied or tape stripped within 4 weeks of the collection day (Day 0).
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- Subject had used a biologic within 12 weeks or 5 half-lives of the collection day (Day 0), whichever was longer.
- Subject had used topical medication, natural health products or medical devices to treat atopic dermatitis or psoriasis on the areas to be tape stripped or biopsied within 2 weeks of the collection day (Day 0).
- Only for subjects who underwent skin biopsy:
- Subject had a known hypersensitivity/allergy to lidocaine.
- Subject had a history of hypertrophic scarring or keloid formation in scars or suture sites.
- Subject was taking anti-coagulant medication (e.g. heparin, low molecular weight [LMW]-heparin, warfarin, anti-platelets [nonsteroidal anti-inflammatory drugs (NSAIDs) and low-dose aspirin (equal or lower than 81 mg) were not considered anti-platelets]) or had a contraindication to skin biopsies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Method to Measure mRNA Levels From the Skin of Patients With Psoriasis and Patients With Atopic Dermatitis Using Tape Strippings
The purpose of this study was to develop a non-invasive method to measure mRNA levels using tape stripping on the skin of patients with psoriasis and patients with atopic dermatitis.
Read the detailed description
Three sequential groups of subjects were recruited in this study for: 1) skin squame collection; 2) tape strip collection; and 3) tape strip and skin biopsy collection in the aim of identifying the most optimal method for measuring the mRNA levels of skin biomarkers in tape strip samples.
- Conditions
- Healthy, Atopic Dermatitis Eczema, Psoriasis
- Being tested
- Skin squame collection, Tape strip collection, Tape strip and skin biopsy collection
- Keywords
- Skin squames, Tape stripping, Skin 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 squame collectionOther
Subjects underwent skin squame collection by scraping. The investigator gently scraped the surface of a lesional skin area for patients with psoriasis, and of a non-lesional skin area for healthy volunteers to collect superficial cells. These samples were analyzed by gene expression analyses.
Tape strip collectionOther
The first subjects had up to 35 tape strips from a maximum of 4 areas (4 X 35 strippings) on the trunk or limbs (excluding the genital area). Patients with atopic dermatitis or psoriasis had tape stripping performed on lesional skin areas and the control subjects had tape stripping performed on nonlesional skin areas. The next subjects were used to determine the optimal number of tape strips required to obtain a good signal by gene expression analyses.
Tape strip and skin biopsy collectionOther
Subjects had tape stripping on up to 3 different skin areas (2 areas on lesional skin and one area of nonlesional skin for patients with atopic dermatitis or psoriasis, and 2 areas of healthy skin for control subjects) using the optimal number of tape strips, as determined in the previous part. One 4-mm skin biopsy on a tape stripped area plus one 4-mm biopsy on non-tape-stripped skin (2 biopsies per subject) were also collected.
| Study group | Role | What they receive |
|---|---|---|
| Skin sample collection | Other | Skin sample collection for gene expression analyses. Receives: Other: Skin squame collection; Other: Tape strip collection; Other: Tape strip and skin biopsy collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of skin biomarkers
Gene expression of epidermal cytokines and chemokines.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start11 May 2017
- Primary completion22 May 2019
- Study completion2 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Sequential
- Model description
- The study consisted of 3 sequential groups: 1. Collection of skin squames by scraping. 2. Collection of tape strip samples. 3. Collection of tape strip samples and skin biopsies.
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovaderm Research Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Bissonnette, MD, Principal investigator, Innovaderm Research Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04537468
- Sponsor's protocol ID
- Inno-5001
- Status last verified
- Sep 2020
- First submitted
- 28 Aug 2020
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
He H, Bissonnette R, Wu J, Diaz A, Saint-Cyr Proulx E, Maari C, Jack C, Louis M, Estrada Y, Krueger JG, Zhang N, Pavel AB, Guttman-Yassky E. Tape strips detect distinct immune and barrier profiles in atopic dermatitis and psoriasis. J Allergy Clin Immunol. 2021 Jan;147(1):199-212. doi: 10.1016/j.jaci.2020.05.048. Epub 2020 Jul 21.
PubMed 32709423
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Method to Measure mRNA Levels From the Skin of Patients With Psoriasis and Patients With Atopic Dermatitis Using Tape Strippings
- ClinicalTrials.gov ID
- NCT04537468
- Acronym / sponsor ID
- Inno-5001
- Conditions
- Healthy, Atopic Dermatitis Eczema, Psoriasis
- Keywords
- Skin squames, Tape stripping, Skin biopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Innovaderm Research Inc.University, hospital or other
- Study start
- 11 May 2017 (actual)
- Primary completion
- 22 May 2019 (actual)
- Study completion
- 2 Oct 2019 (actual)
- First posted
- 3 Sep 2020 (actual)
- 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.
The purpose of this study was to develop a non-invasive method to measure mRNA levels using tape stripping on the skin of patients with psoriasis and patients with atopic dermatitis.
Detailed description
Three sequential groups of subjects were recruited in this study for: 1) skin squame collection; 2) tape strip collection; and 3) tape strip and skin biopsy collection in the aim of identifying the most optimal method for measuring the mRNA levels of skin biomarkers in tape strip samples.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study consisted of 3 sequential groups: 1. Collection of skin squames by scraping. 2. Collection of tape strip samples. 3. Collection of tape strip samples and skin biopsies.
| Arm | Type | Receives |
|---|---|---|
| Skin sample collection | Other | Other: Skin squame collection, Other: Tape strip collection, Other: Tape strip and skin biopsy collectionSkin sample collection for gene expression analyses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject, male or female, aged 18 years or older at the time of consent.
- Female subjects of childbearing potential had a negative urine pregnancy test at the screening visit.
- Subjects had to be able and willing to provide written informed consent and comply with the requirements of the study protocol. Consent was obtained prior to any study-related procedures.
- Patient had a history of atopic dermatitis or psoriasis.
- Patient with psoriasis had a Physician's Global Assessment (PGA) score of ≥2 at Day 0.
Key exclusion criteria (12 listed)
- Female subject was pregnant or breastfeeding.
- Subject was participating in a clinical trial with an experimental drug or device or had participated in a clinical trial with an experimental drug or device within the last 4 weeks of the collection day (Day 0).
- Subject was known to have hepatitis B or hepatitis C viral infection.
- Subject was known to have immune deficiency or was immunocompromised.
- Subject had used systemic medication, medical devices, UVB or PUVA therapy or natural health products to treat atopic dermatitis or psoriasis on the areas to be biopsied or tape stripped within 4 weeks of the collection day (Day 0).
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 squame collectionSubjects underwent skin squame collection by scraping. The investigator gently scraped the surface of a lesional skin area for patients with psoriasis, and of a non-lesional skin area for healthy volunteers to collect superficial cells. These samples were analyzed by gene expression analyses. | Other | Skin sample collection |
| Tape strip collectionThe first subjects had up to 35 tape strips from a maximum of 4 areas (4 X 35 strippings) on the trunk or limbs (excluding the genital area). Patients with atopic dermatitis or psoriasis had tape stripping performed on lesional skin areas and the control subjects had tape stripping performed on nonlesional skin areas. The next subjects were used to determine the optimal number of tape strips required to obtain a good signal by gene expression analyses. | Other | Skin sample collection |
| Tape strip and skin biopsy collectionSubjects had tape stripping on up to 3 different skin areas (2 areas on lesional skin and one area of nonlesional skin for patients with atopic dermatitis or psoriasis, and 2 areas of healthy skin for control subjects) using the optimal number of tape strips, as determined in the previous part. One 4-mm skin biopsy on a tape stripped area plus one 4-mm biopsy on non-tape-stripped skin (2 biopsies per subject) were also collected. | Other | Skin sample collection |
Primary outcome
Expression of skin biomarkers
Time frame: Day 0
Gene expression of epidermal cytokines and chemokines.
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 Sep 2020.
- Results publication: PubMed 32709423He H, Bissonnette R, Wu J, Diaz A, Saint-Cyr Proulx E, Maari C, Jack C, Louis M, Estrada Y, Krueger JG, Zhang N, Pavel AB, Guttman-Yassky E. Tape strips detect distinct immune and barrier profiles in atopic dermatitis and psoriasis. J Allergy Clin Immunol. 2021 Jan;147(1):199-212. doi: 10.1016/j.jaci.2020.05.048. Epub 2020 Jul 21.
- 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.
Robert Bissonnette, MD principal investigator
Innovaderm Research Inc.
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 squame collection, Tape strip collection and Tape strip and skin biopsy collection in people with Healthy and Atopic Dermatitis Eczema, run by Innovaderm Research Inc. at 1 site in Canada.
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 12 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 Sep 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 Canada. 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?
Expression of skin biomarkers (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04537468, which also lists 1 linked publication.
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 Sep 2020.