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A Prospective Sample Collection Study Using Non-invasive Methods to Investigate Biomarkers in AD Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04699695
Recruitment Status : Recruiting
First Posted : January 7, 2021
Last Update Posted : July 26, 2022
Sponsor:
Information provided by (Responsible Party):
DermTech

Study Description
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Brief 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). Samples collected will be analyzed to detect gene signatures and microbiome populations associated with AD and sub-populations of AD.

Condition or disease Intervention/treatment
Atopic Dermatitis Other: Biologic therapy versus no biologic therapy

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
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Multicenter Sample Collection Study Using Non-invasive Methods to Investigate Biomarkers in Pediatric and Adult Patients With Atopic Dermatitis
Actual Study Start Date : February 15, 2021
Estimated Primary Completion Date : October 15, 2024
Estimated Study Completion Date : April 15, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Biologic Treatment
Subjects prescribed a biologic agent per standard of care
 Other: Biologic therapy versus no biologic therapy
Biologic therapy administered per standard of care
Other Treatments
Subjects prescribed other treatment modalities exclusive of biologic therapy per standard of care
 Other: Biologic therapy versus no biologic therapy
Biologic therapy administered per standard of care


Outcome Measures
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Primary Outcome Measures :
  1. Gene expression with primary disease assessment EASI [ Time Frame: Week 16 ]
    Expression of genes with disease activity measures including the EASI score


Secondary Outcome Measures :
  1. Gene expression correlated with POEM assessment [ Time Frame: Week 16 ]
    Expression of genes in the DermTech assay with POEM disease activity

  2. Gene expression correlated with IGA assessment [ Time Frame: Week 16 ]
    Expression of genes in the DermTech assay with IGA disease activity

  3. Gene expression correlated with TEWL assessment [ Time Frame: Week 16 ]
    Expression of genes in the DermTech assay with TEWL

  4. Gene expression correlated with PRNS assessment [ Time Frame: Week 16 ]
    Expression of genes in the DermTech asssay with PPRNS


Biospecimen Retention:   Samples With DNA
samples collected non-invasively will be assess for nucleic acids and microbiome

Eligibility Criteria
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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Approximately 500 pediatric and adult subjects with moderate to severe atopic dermatitis will be enrolled in this study
Criteria

Inclusion Criteria:

  1. Males and females at least 1 year of age;
  2. Subjects with documented, active moderate to severe atopic dermatitis;
  3. Subjects must have a history of atopic dermatitis for at least three months;
  4. Subjects with no known reactions to adhesives;
  5. 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;
  6. Subjects willing to follow standard of care (SOC) for his/her atopic dermatitis; and
  7. Subjects must be able to complete all study visits required by the protocol.

Exclusion Criteria:

  1. Pregnant or breast feeding, including positive pregnancy test at baseline or expected to become pregnant during participation in the trial;
  2. 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);
  3. Current acute infectious illness (viral, parasitic or bacterial) within 4 weeks of enrollment;
  4. Receipt of systemic anti-atopic dermatitis medication, including retinoids, corticosteroids, cyclosporine, methotrexate within the four weeks of the Baseline Visit;
  5. Use of topical therapy (except emollients) for atopic dermatitis or any other condition within two weeks of the Baseline Visit;
  6. 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
  7. 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04699695


Contacts
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Contact: James Rock 18582052736 jrock@dermtech.com
Contact: Susan Huynh 8584504222 susan.huynh@dermtech.com

Locations
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United States, New York
Orit Markowitz Recruiting
New York, New York, United States, 10128
Contact: Orit Markowitz, MD    212-828-3120      
Contact: Moshe Bressler, DO    2128283120    moshe@optiskinmedical.com   
Lisa A. Beck Recruiting
Rochester, New York, United States, 14620
Contact: Jo Anne VanBuskirk, BS, CCRP    585-276-4600    JoAnne_VanBuskirk@URMC.Rochester.edu   
Sponsors and Collaborators
DermTech
More Information
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Publications:

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Responsible Party: DermTech
ClinicalTrials.gov Identifier: NCT04699695    
Other Study ID Numbers: DermTech 20-03
First Posted: January 7, 2021    Key Record Dates
Last Update Posted: July 26, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual data will not be shared with other researchers and patient data will be de-identified.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by DermTech:
DermTech
Biologics
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
 Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases