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

NCT04699695 | Unknown

• 1 other identifier: DermTech 20-03
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 2

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.

Conditions

Atopic Dermatitis

Keywords

DermTech; Biologics

Outcome Measures

Primary Outcomes (1)

• Gene expression with primary disease assessment EASI

  Expression of genes with disease activity measures including the EASI score

  Week 16

Secondary Outcomes (4)

• Gene expression correlated with POEM assessment

  Week 16

• Gene expression correlated with IGA assessment

  Week 16

• Gene expression correlated with TEWL assessment

  Week 16

• Gene expression correlated with PRNS assessment

  Week 16

Study Arms (2)

Biologic Treatment

Subjects prescribed a biologic agent per standard of care

Other: Biologic therapy versus no biologic therapy

Other Treatments

Subjects prescribed other treatment modalities exclusive of biologic therapy per standard of care

Other: Biologic therapy versus no biologic therapy

Interventions

Biologic therapy versus no biologic therapy OTHER

Biologic therapy administered per standard of care

Biologic Treatment; Other Treatments

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• DermTech: lead

Study Sites (2)

Orit Markowitz

New York, New York, 10128, United States

RECRUITING

Lisa A. Beck

Rochester, New York, 14620, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 29036251 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

samples collected non-invasively will be assess for nucleic acids and microbiome

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

James Rock

CONTACT

18582052736; jrock@dermtech.com

Susan Huynh

CONTACT

8584504222; susan.huynh@dermtech.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2021
• First Posted: January 7, 2021
• Study Start: February 15, 2021
• Primary Completion: October 15, 2024
• Study Completion: April 15, 2025
• Last Updated: July 26, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)