Nocturnal scratching is a significant burden for individuals with Atopic Dermatitis (AD) and Psoriasis, leading to sleep disruption, skin damage, and reduced quality of life. Digital measures using wearable sensors offer a promising approach to objectively quantify scratching behavior in real-world settings, providing valuable insights for clinical research and personalized treatment.

Building upon prior work conducted through DEEP by other consortia, this initiative aims to accelerate the clinical validation and regulatory acceptance of digital measures for nocturnal scratching in AD and Psoriasis.

 

Overall Goal:

Leverage Prior Work: Utilize existing knowledge and resources from previous DEEP projects on digital measurement of scratching in AD and Psoriasis.

Design Robust Clinical Validation Studies: Develop comprehensive study protocols to assess the validity, reliability, and clinical meaningfulness of digital scratch measures against established clinical endpoints and patient-reported outcomes.

Engage with Regulatory Agencies: Seek feedback from the FDA on the proposed clinical validation study design to ensure alignment with regulatory expectations and streamline the path towards acceptance.

 

Specific Objectives:

Review existing literature and data from prior DEEP projects to identify validated digital biomarkers of nocturnal scratching in AD and Psoriasis.

Design clinical validation studies that incorporate:

Clear inclusion/exclusion criteria for AD and Psoriasis populations

Rigorous methodology for data collection using wearable sensors

Appropriate comparators (e.g., polysomnography, patient diaries)

Analysis plan to assess correlation with clinical endpoints and patient-reported outcomes

Establishment of minimally important differences (MIDs)

3 . Engage with the regulators to seek feedback on the proposed study design and discuss potential pathways for regulatory acceptance.

 

Potential Benefits:

Accelerated Drug Development: Validated digital endpoints can streamline clinical trials for new therapies targeting itch and sleep disturbance in these conditions.

Regulatory Clarity: Early engagement with the FDA can provide valuable guidance and increase the likelihood of regulatory acceptance for digital scratch measures.

Enhanced Collaboration: Leveraging prior DEEP work and engaging with regulatory agencies fosters collaboration and accelerates progress in the field.

 

Call for Collaboration:

This initiative invites stakeholders involved in AD and Psoriasis research, care, and treatment, including:

Pharmaceutical companies with AD and Psoriasis therapies in their pipeline

Wearable sensor manufacturers

Academic researchers with expertise in dermatology and digital health

Dermatologists and other healthcare professionals

Patient advocacy groups

 

Ways of contributing to a DEEP collaboration mission:

There are many ways that you can contribute to a DEEP collaboration mission. Contributions can be in the form of funding, time & expertise or prior work you have completed and would like to contribute to the cause in exchange for other contributions. DEEP's built in legal framework and mission contracting services aim to simplify the process of collaboration for all partners who would like to engage.

 

If you have questions, or if your organization is interested in contributing, please reach out to us here: