Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||1 Year and Over|
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.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
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. Samples collected will be analyzed to detect gene signatures and microbiome populations associated with atopic dermatitis and sub-populations of AD. Approximately 500 pediatric and adult subjects with moderate to severe AD will be enrolled in this study. Non-invasive skin samples will be collected at baseline, before drug administration 16 weeks (+/- 2 weeks) after treatment with biological therapy and a final visit at 26 weeks ((+/- 4 weeks). Subjects will enter the Screening Period once the informed consent and/or assent process has been completed. Once patient eligibility is confirmed, non-invasive skin samples will be collected using DermTech's non-invasive sample collection kit. Samples will be collected from the following areas:
- - Target Lesion - lesional skin for genomic analysis.
- - Lesional skin for microbiome analysis similar in size and severity to the target lesion noted above.
- - Non-lesional skin at least 5 cm from any active lesion.
: 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
Other: - Biologic therapy versus no biologic therapy
Biologic therapy administered per standard of care
This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:
For additional contact information, you can also visit the trial on clinicaltrials.gov.