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

Status unconfirmed

Conditions studied: Atopic Dermatitis

In brief

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.

Key facts

Study ID

NCT04699695

Run by

DermTech

People needed

500

Starts

2021-02-15

Expected to finish

2025-04-15

Last updated by the study team

2022-07-26

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Orit Markowitz — New York, New York, United States (enrolling)
• Lisa A. Beck — Rochester, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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