Atopic DermatitisNCT04699695
A Prospective Sample Collection Study Using Non-invasive Methods to Investigate Biomarkers in AD Patients
An observational study of Atopic Dermatitis, run by DermTech at 2 sites in United States.
Trial summary
This is a prospective, multicenter, sample collection study using DermTech's non-invasive skin collection kits to evaluate genomic biomarkers and microbiome information from pediatric and adult subjects with atopic dermatitis(AD). Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Biologic therapy versus no biologic therapy
- How many people
- 500 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Feb 2021to 15 Apr 2025
- Phase
- Observational
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Approximately 500 pediatric and adult subjects with moderate to severe atopic dermatitis will be enrolled in this study
Who may be able to join
- Males and females at least 1 year of age;
- Subjects with documented, active moderate to severe atopic dermatitis;
- Subjects must have a history of atopic dermatitis for at least three months;
- Subjects with no known reactions to adhesives;
- Subject has a sufficient number of target plaques on the central body, which includes knees or elbows, and not limited to lesions on the mucosal membranes, soles of the feet or palms of the hands;
- Subjects willing to follow standard of care (SOC) for his/her atopic dermatitis; and
- Subjects must be able to complete all study visits required by the protocol.
Who cannot join
- Pregnant or breast feeding, including positive pregnancy test at baseline or expected to become pregnant during participation in the trial;
- History of cancer (exceptions for: a) non-metastatic malignancy deemed cured at the time of enrollment, b) skin cancer that has been excised with controlled margins or has not recurred in 6 months; and c) treated cervical cancer in situ);
- Current acute infectious illness (viral, parasitic or bacterial) within 4 weeks of enrollment;
- Receipt of systemic anti-atopic dermatitis medication, including retinoids, corticosteroids, cyclosporine, methotrexate within the four weeks of the Baseline Visit;
- Use of topical therapy (except emollients) for atopic dermatitis or any other condition within two weeks of the Baseline Visit;
- Receipt of any investigational drug therapy within four weeks or 5 half-lives, whichever is longer of study enrollment, or concurrent participation in another interventional clinical study; and
- Documented substance abuse, any other significant medical condition or laboratory result that would indicate an unreasonable risk to the subject or potential interference with study procedures, or would negatively affect the patient's reliability and compliance with the study schedule.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Orit Markowitz
New York, New York, 10128
Orit Markowitz, MD, 212-828-3120
Moshe Bressler, DO, 2128283120, moshe@optiskinmedical.com
- Recruiting
Lisa A. Beck
Rochester, New York, 14620
Jo Anne VanBuskirk, BS, CCRP, 585-276-4600, JoAnne_VanBuskirk@URMC.Rochester.edu
About this study
Official title: A Prospective Multicenter Sample Collection Study Using Non-invasive Methods to Investigate Biomarkers in Pediatric and Adult Patients With Atopic Dermatitis
This is a prospective, multicenter, sample collection study using DermTech's non-invasive skin collection kits to evaluate genomic biomarkers and microbiome information from pediatric and adult subjects with atopic dermatitis(AD). Samples collected will be analyzed to detect gene signatures and microbiome populations associated with AD and sub-populations of AD.
Read the detailed description
This is a prospective, multicenter, sample collection study using DermTech's non-invasive skin collection kits to evaluate genomic biomarkers and microbiome information from pediatric and adult subjects with atopic dermatitis. Samples collected will be analyzed to detect gene signatures and microbiome populations associated with atopic dermatitis and sub-populations of AD.
Approximately 500 pediatric and adult subjects with moderate to severe AD will be enrolled in this study. Non-invasive skin samples will be collected at baseline, before drug administration 16 weeks (+/- 2 weeks) after treatment with biological therapy and a final visit at 26 weeks ((+/- 4 weeks).
Subjects will enter the Screening Period once the informed consent and/or assent process has been completed.
Once patient eligibility is confirmed, non-invasive skin samples will be collected using DermTech's non-invasive sample collection kit.
Samples will be collected from the following areas:
- Target Lesion - lesional skin for genomic analysis. Please note the location for subsequent collections.
- Lesional skin for microbiome analysis similar in size and severity to the target lesion noted above. Please note the location for subsequent collections.
- Non-lesional skin at least 5 cm from any active lesion. The intervals for subsequent sample collection, if applicable, will be determined based on standard of care (SOC) treatment and the subject's willingness to undergo repeat non-invasive sampling.
Data to be collected includes eczema area and severity index (EASI), patient oriented eczema measure (POEM), investigator global assessment (IGA), peak pruritus numerical rating scale (PPNRS), and transepidermal water loss (TEWL).
Photographic documentation of the site(s) sampled should be obtained to confirm consistent sampling of the lesional and non-lesional sites. Each non-invasive sample collection will consist of sequential application of 4 individual patches to a site. If during active treatment the skin lesion disappears during active treatment, skin samples will still be obtained from the same location.
- Conditions
- Atopic Dermatitis
- Being tested
- Biologic therapy versus no biologic therapy
- Keywords
- DermTech, Biologics
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biologic therapy versus no biologic therapyOther
Biologic therapy administered per standard of care
| Study group | Role | What they receive |
|---|---|---|
| Biologic Treatment | Subjects prescribed a biologic agent per standard of care Receives: Other: Biologic therapy versus no biologic therapy | |
| Other Treatments | Subjects prescribed other treatment modalities exclusive of biologic therapy per standard of care Receives: Other: Biologic therapy versus no biologic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene expression with primary disease assessment EASI
Expression of genes with disease activity measures including the EASI score
Measured: Week 16
Secondary outcomes (4)
Gene expression correlated with POEM assessment
Expression of genes in the DermTech assay with POEM disease activity
Measured: Week 16
Gene expression correlated with IGA assessment
Expression of genes in the DermTech assay with IGA disease activity
Measured: Week 16
Gene expression correlated with TEWL assessment
Expression of genes in the DermTech assay with TEWL
Measured: Week 16
Gene expression correlated with PRNS assessment
Expression of genes in the DermTech asssay with PPRNS
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start15 Feb 2021
- Primary completion15 Oct 2024 (estimated)
- Study completion15 Apr 2025 (estimated)
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 Atopic DermatitisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DermTech
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04699695
- Sponsor's protocol ID
- DermTech 20-03
- Status last verified
- Mar 2022
- First submitted
- 5 Jan 2021
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual data will not be shared with other researchers and patient data will be de-identified.
Publications
Yao Z, Moy R, Allen T, Jansen B. An Adhesive Patch-Based Skin Biopsy Device for Molecular Diagnostics and Skin Microbiome Studies. J Drugs Dermatol. 2017 Oct 1;16(10):979-986.
PubMed 29036251
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Sample Collection Study Using Non-invasive Methods to Investigate Biomarkers in Pediatric and Adult Patients With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT04699695
- Acronym / sponsor ID
- DermTech 20-03
- Conditions
- Atopic Dermatitis
- Keywords
- DermTech, Biologics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- DermTechUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 15 Oct 2024 (estimated)
- Study completion
- 15 Apr 2025 (estimated)
- First posted
- 7 Jan 2021 (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.
This is a prospective, multicenter, sample collection study using DermTech's non-invasive skin collection kits to evaluate genomic biomarkers and microbiome information from pediatric and adult subjects with atopic dermatitis(AD). Samples collected will be analyzed to detect gene signatures and microbiome populations associated with AD and sub-populations of AD.
Detailed description
This is a prospective, multicenter, sample collection study using DermTech's non-invasive skin collection kits to evaluate genomic biomarkers and microbiome information from pediatric and adult subjects with atopic dermatitis. Samples collected will be analyzed to detect gene signatures and microbiome populations associated with atopic dermatitis and sub-populations of AD.
Approximately 500 pediatric and adult subjects with moderate to severe AD will be enrolled in this study. Non-invasive skin samples will be collected at baseline, before drug administration 16 weeks (+/- 2 weeks) after treatment with biological therapy and a final visit at 26 weeks ((+/- 4 weeks).
Subjects will enter the Screening Period once the informed consent and/or assent process has been completed.
Once patient eligibility is confirmed, non-invasive skin samples will be collected using DermTech's non-invasive sample collection kit.
Samples will be collected from the following areas:
- Target Lesion - lesional skin for genomic analysis. Please note the location for subsequent collections.
- Lesional skin for microbiome analysis similar in size and severity to the target lesion noted above. Please note the location for subsequent collections.
- Non-lesional skin at least 5 cm from any active lesion. The intervals for subsequent sample collection, if applicable, will be determined based on standard of care (SOC) treatment and the subject's willingness to undergo repeat non-invasive sampling.
Data to be collected includes eczema area and severity index (EASI), patient oriented eczema measure (POEM), investigator global assessment (IGA), peak pruritus numerical rating scale (PPNRS), and transepidermal water loss (TEWL).
Photographic documentation of the site(s) sampled should be obtained to confirm consistent sampling of the lesional and non-lesional sites. Each non-invasive sample collection will consist of sequential application of 4 individual patches to a site. If during active treatment the skin lesion disappears during active treatment, skin samples will still be obtained from the same location.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biologic Treatment | – | Other: Biologic therapy versus no biologic therapySubjects prescribed a biologic agent per standard of care |
| Other Treatments | – | Other: Biologic therapy versus no biologic therapySubjects prescribed other treatment modalities exclusive of biologic therapy per standard of care |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Approximately 500 pediatric and adult subjects with moderate to severe atopic dermatitis will be enrolled in this study
Key inclusion criteria (7 listed)
- Males and females at least 1 year of age;
- Subjects with documented, active moderate to severe atopic dermatitis;
- Subjects must have a history of atopic dermatitis for at least three months;
- Subjects with no known reactions to adhesives;
- Subject has a sufficient number of target plaques on the central body, which includes knees or elbows, and not limited to lesions on the mucosal membranes, soles of the feet or palms of the hands;
Key exclusion criteria (7 listed)
- Pregnant or breast feeding, including positive pregnancy test at baseline or expected to become pregnant during participation in the trial;
- History of cancer (exceptions for: a) non-metastatic malignancy deemed cured at the time of enrollment, b) skin cancer that has been excised with controlled margins or has not recurred in 6 months; and c) treated cervical cancer in situ);
- Current acute infectious illness (viral, parasitic or bacterial) within 4 weeks of enrollment;
- Receipt of systemic anti-atopic dermatitis medication, including retinoids, corticosteroids, cyclosporine, methotrexate within the four weeks of the Baseline Visit;
- Use of topical therapy (except emollients) for atopic dermatitis or any other condition within two weeks of the 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 |
|---|---|---|
| Biologic therapy versus no biologic therapyBiologic therapy administered per standard of care | Other | Biologic Treatment, Other Treatments |
Primary outcome
Gene expression with primary disease assessment EASI
Time frame: Week 16
Expression of genes with disease activity measures including the EASI score
4 secondary outcomes
Gene expression correlated with POEM assessment
Time frame: Week 16
Gene expression correlated with IGA assessment
Time frame: Week 16
Gene expression correlated with TEWL assessment
Time frame: Week 16
Gene expression correlated with PRNS assessment
Time frame: Week 16
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Background: PubMed 29036251Yao Z, Moy R, Allen T, Jansen B. An Adhesive Patch-Based Skin Biopsy Device for Molecular Diagnostics and Skin Microbiome Studies. J Drugs Dermatol. 2017 Oct 1;16(10):979-986.
- Individual participant dataSharing planned: No. Individual data will not be shared with other researchers and patient data will be de-identified.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis, run by DermTech at 2 sites 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 7 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: status not confirmed, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James Rock (18582052736, jrock@dermtech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gene expression with primary disease assessment EASI (time frame: Week 16). 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 NCT04699695, 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 26 Jul 2022.