Status:
UNKNOWN
A Prospective Sample Collection Study Using Non-invasive Methods to Investigate Biomarkers in AD Patients
Lead Sponsor:
DermTech
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
1+ years
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 subjec...
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 subjec...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 15 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 15 2025
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04699695
Start Date
February 15 2021
End Date
April 15 2025
Last Update
July 26 2022
Active Locations (2)
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1
Orit Markowitz
New York, New York, United States, 10128
2
Lisa A. Beck
Rochester, New York, United States, 14620