Recruiting

Biomarkers in AD

Sponsor:

DermTech

Code:

NCT04699695

Conditions

Atopic Dermatitis

Eligibility Criteria

Sex: All

Age: 1+

Healthy Volunteers: Not accepted

Interventions

Biologic therapy versus no biologic therapy

Study Details

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

Study ID

NCT04699695

Start date

Feb 15, 2021

Status verified date

Mar, 2022

Completion date

Apr 15, 2025

Anticipated

Primary completion date

Oct 15, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Biologic Treatment

Subjects prescribed a biologic agent per standard of care

Other Treatments

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

Interventions

Biologic therapy versus no biologic therapy

Biologic therapy administered per standard of care

Primary outcome measure

  • Gene expression with primary disease assessment EASI [ Time Frame: Week 16 ]

Central Contacts and Locations

Locations

Orit Markowitz

Recruiting

New York, New York, United States, 10128

Contacts

Orit Markowitz, MD

212-828-3120

Lisa A. Beck

Recruiting

Rochester, New York, United States, 14620

Contacts

More Information

Sponsor

DermTech

Last update posted

Jul 26, 2022

Last verified

Mar, 2022

Keywords

  • DermTech
  • Biologics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by DermTech on 2022-07-26.