Harness Digital Measurement of Nocturnal Scratch in Atopic Dermatitis

Atopic dermatitis (AD) is a chronic inflammatory skin condition that affects up to 2.6% of the population1, with the itch-scratch cycle being one of the most burdensome symptoms. One of the most significant challenges in managing AD is the lack of objective measures to evaluate the severity and impact of scratching, particularly during sleep. This gap in measurement has limited the ability to fully understand the disease and develop targeted interventions.

Enter Biofourmis and our new digital measure for nocturnal scratch that offers a range of opportunities to enhance drug development programs for atopic dermatitis and beyond. Delivered in collaboration with a leading pharmaceutical company, the clinically validated tool utilizes machine-learning algorithms and accelerometry from wearable sensors to provide continuous digital measures of nighttime scratching and sleep quality2.

Why Measure Nocturnal Scratch?

The itch-scratch cycle is one of the most predominant and burdensome symptoms of atopic dermatitis that cause significant damage to the skin barrier, which can lead to infections and inflammation that further exacerbate the condition. Traditionally, the measurement of scratching has relied heavily on patient self-reporting and clinician observations, both of which are subjective and open to bias. Our objective digital measurement of nocturnal scratching offers several important advantages:

• Evidence of Effectiveness: By accurately measuring the incidence in scratching, researchers can better identify which treatments are most effective. This can lead to more targeted therapies and improved patient outcomes.
• Clinically Meaningful Measure: Unlike subjective observational reports, the passive digital measurement of nocturnal scratching provides unbiased data that could provide more reliability and consistency. This may provide additional context to clinical trial results and support the regulatory approval process.
• Comprehensive Insights: Combining patient-reported outcomes (PROs) with digital health technologies (DHTs) such as our nocturnal scratch measure provides a holistic view of patient health. This integration offers deeper insights into the disease and its impact on patients' lives.

Objective measure for atopic dermatitis research

Five years of development has gone into the underlying scratch and sleep algorithms. Evaluated in over 200 individuals (age 2 to 75) with atopic dermatitis 3?????, the digital measures showed high correlation with corresponding reference measures of sleep quantity (obtained from PSG) and scratch (obtained from in-clinic video recordings)2. The solution is designed to be device-agnostic, making it a versatile tool for assessing efficacy in AD drug development programs.

The nocturnal scratch digital measure will be available on the Biofourmis? platform, creating an integrated research and development tool for atopic dermatitis. When combined with the Biofourmis digital clinical trial toolkit – which includes a participant app, eConsent, ePRO, and wearable sensors – the solution aims to offer a comprehensive and user-friendly experience for trial participants.

?

The Path Forward

There are multiple benefits of incorporating digital nocturnal scratch measurement into AD drug development programs. It provides objective data helping researchers to evaluate the most effective treatments, and alongside traditional measures may offer a more complete picture of patient health. And the potential of this technology extends beyond AD – Biofourmis plans to explore expanding the application of this tool to other dermatological conditions, such as psoriasis, further broadening its impact and utility.

As we look to the future, the integration of digital measures like nocturnal scratch into drug development programs represents a significant opportunity to advance precision medicine and improve patient outcomes. By leveraging innovative technologies and objective data, we can transform the landscape of clinical research and pave the way for more effective and personalized treatments.

At Biofourmis, we are committed to driving this transformation and supporting the development of next-generation therapies. Join us on this journey as we harness the power of digital health to create a brighter future for patients worldwide.

To learn more about the new digital measure for nocturnal scratching and sleep quality, and how it can enhance your clinical trial programs, visit us at DPHARM (Sept 17-18) in Philadelphia, or download our brochure on Nocturnal Scratch Digital Measurement from Biofourmis.com

?

References:

1. Tian J, Zhang D, Yang Y, Huang Y, Wang L, Yao X, Lu Q. Global epidemiology of atopic dermatitis: a comprehensive systematic analysis and modelling study. Br J Dermatol. 2023 Dec 20;190(1):55-61. doi: 10.1093/bjd/ljad339. PMID: 37705227.
2. Mahadevan, N., Christakis, Y., Di, J.?et al.?Development of digital measures for nighttime scratch and sleep using wrist-worn wearable devices.?npj Digit. Med.?4, 42 (2021). https://doi.org/10.1038/s41746-021-00402-x
3. Scratch and Sleep Quantification in Atopic Dermatitis (SQUAD) (ClinicalTrials.gov: NCT03490877)
4. Monitoring of Scratch via Accelerometry in Children (MOSAIC) (ClinicalTrials.gov: NCT03873220)
5. Scratch Behavior Under Standard of Care (SOC) (ClinicalTrials.gov: NCT03898427)