NCT04699695

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: DermTech · Academic / Other
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

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.

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 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. Please note the location for subsequent collections. * Lesional skin for microbiome analysis similar in size and severity to the target lesion noted above. Please note the location for subsequent collections. * Non-lesional skin at least 5 cm from any active lesion. The intervals for subsequent sample collection, if applicable, will be determined based on standard of care (SOC) treatment and the subject's willingness to undergo repeat non-invasive sampling. Data to be collected includes eczema area and severity index (EASI), patient oriented eczema measure (POEM), investigator global assessment (IGA), peak pruritus numerical rating scale (PPNRS), and transepidermal water loss (TEWL). Photographic documentation of the site(s) sampled should be obtained to confirm consistent sampling of the lesional and non-lesional sites. Each non-invasive sample collection will consist of sequential application of 4 individual patches to a site. If during active treatment the skin lesion disappears during active treatment, skin samples will still be obtained from the same location.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
OTHER	Biologic therapy versus no biologic therapy	Biologic therapy administered per standard of care

Timeline

• Start date: 2021-02-15
• Primary completion: 2024-10-15
• Completion: 2025-04-15
• First posted: 2021-01-07
• Last updated: 2022-07-26

Locations

2 sites across 1 country: United States