RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

A Prospective Multicenter Sample Collection Study Using Non-invasive Methods to Investigate Biomarkers in Pediatric and Adult Patients With Atopic Dermatitis

Quick Facts

Study Start:2021-02-15

Study Completion:2025-04-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04699695

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Year

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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

Study Contact

James Rock

CONTACT

18582052736

jrock@dermtech.com

Susan Huynh

CONTACT

8584504222

susan.huynh@dermtech.com

Study Locations (Sites)

Orit Markowitz

New York, New York, 10128

United States

Lisa A. Beck

Rochester, New York, 14620

United States

Collaborators and Investigators

Sponsor: DermTech

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-02-15

Study Completion Date2025-04-15

Study Record Updates

Study Start Date2021-02-15

Study Completion Date2025-04-15

Terms related to this study

Keywords Provided by Researchers

DermTech
Biologics

Additional Relevant MeSH Terms

Atopic Dermatitis