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Nocturnal Scratch Program

We are building on groundbreaking work outlined below:

Nocturnal scratching significantly impacts the lives of millions suffering from atopic dermatitis and psoriasis. While promising digital solutions may exist, we lack validated measures for clinical trials and patient care. DEEP is spearheading efforts to change this.

 

About the Program

 

We are aiming to create regulatory accepted digital measures for nocturnal scratch. We are building on groundbreaking work by:

 

  • DiMe: Adoption of Nocturnal Scratch as a Digital Endpoint.  A collaborative effort to establish nocturnal scratch as a digital endpoint for atopic dermatitis.
    Read more

  • DEEP-EMA Pilot: Advancing Digital Endpoints in Atopic Dermatitis. This initiative aimed to standardize nocturnal scratch measurement, enhancing assessment and treatment of atopic dermatitis. 
    Read more

  • DECODE: Nocturnal Scratch: A cross-industry collaboration to develop a  digital measure for dermatological conditions such as atopic dermatitis (AD) and psoriasis.
    Read more

Our Missions

 

We're launching two collaborative missions to develop and validate digital measures for nocturnal scratch assessment, focusing on meeting FDA and EMA regulatory requirements.

Clinical Validation Mission

Mission to clinically validate nocturnal scratch in Atopic Dermatitis (AD) in an independent highly optimized and efficient clinical validation study incorporating design inputs from all participating companies to cover their needs.

 

  • Understand the interpretation of scratch (in the itch-scratch cycle) to be able to demonstrate and articulate to regulators the meaningfulness of measuring nocturnal scratch in patients with these conditions.

  • Objectively quantify scratching behavior in real-world settings

  • Establish clinically meaningful endpoints for clinical trials

  • Accelerate therapy development through innovative measures

  • Explore different measurement modalities (wrist worn, ring based, contactless) and chose the right one for patients in your clinical trial.

Relevance of Nocturnal Scratch in Psorasis   

Mission to determine the relevance of nocturnal scratch in psoriasis and extend the nocturnal scratch measure in this context of use.

 

  • Discover how patients with Psoriasis and Atopic Dermatitis experience itch and scratch differently, learn what evidence is needed to extend a nocturnal scratch measure into a new context of use.

  • Draw correlations between nocturnal scratch and other measures of the disease to generate evidence of convergent validity and make more specific claims with the regulators based on measurable impact on patients lives.

How You Can Contribute

We're seeking experts to join our multi-stakeholder working groups and contribute:

  • Regulatory and scientific expertise

  • Insights on dermatology and sleep science

  • Support in creating an accepted digital measure for nocturnal scratch

What DEEP offers

The DEEP services and collaboration tools equip teams working in DEEP with everything they need to develop digital measures and enable more efficient collaboration along the way. The DEEP digital measure builder, powered by the Stack model, is a framework that enables structuring of evidence, the identification of evidence gaps and efficient information exchange with regulators. The stack model also promotes content reuse across new solutions or contexts of use.

Next Steps   

Thank you for your commitment to advancing digital measures of health. Together, we can enhance the quality of life for millions affected by nocturnal scratching.  

 

Contact us if you want to be a part of a co-creation team to advance digital measures for these or other programs. 

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