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THERAPEUTIC EXPERTISE

Solutions for Dermatology Research

Scratching behavior is a disruptive symptom that is common in many dermatological conditions and substantially worsens quality of life through its debilitating effects, including disrupted sleep. Digital health technologies (DHTs) provide a continuous, objective measure of nocturnal scratch and sleep to assess efficacy of treatments and document patient-centric benefits.

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Indications Where DHTs Have Been Included in Clinical Development

  • Atopic Dermatitis
  • Psoriasis
  • Chronic Spontaneous Urticaria
  • Dermatomyositis
  • Purigo Nodularis (PN)

Selected Digital Endpoints for Dermatology Research

Nocturnal Scratch

  • Scratch Duration
  • Number of Scratch Bouts
  • Frequency of Scratch
  • Average hourly duration of scratch

Sleep

  • Total Sleep Time
  • Wake After Sleep Onset (WASO)
  • Sleep Onset Latency
  • Sleep Efficiency
Nocturnal Scratch
  • Scratch Duration
  • Number of Scratch Bouts
  • Frequency of Scratch
  • Average hourly duration of scratch
Sleep
  • Total Sleep Time
  • Wake After Sleep Onset (WASO)
  • Sleep Onset Latency
  • Sleep Efficiency

Dermatology Digital Endpoint Guide

To learn more about opportunities with wearable digital health technologies in respiratory disease clinical trials, download our full guide.

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Nocturnal Scratch Detection

Scratching during night plays a significant role in many dermatological diseases. Nocturnal scratch is associated with substantive sleep impairments and worsening of skin conditions, and research supports that this symptom is a meaningful aspect of health in patients’ lives. 

However, due to the nocturnal nature of this symptom, patients might not be able to report it accurately. Several cross-industry efforts (1,2,3) have established nocturnal scratch as one of the most mature digital endpoints, helping researchers capture reliable and accurate measures.

Comprehensive insights from continuous, objective measures of nocturnal scratch and sleep provide a holistic view of patient health and can support robust evidence packages. Researchers and sponsors can now capture the incidence of scratching using DHTs to develop more patient-centric treatments, differentiate from their competitors, and better negotiate with payers.

Learn about our Nocturnal Scratch solution

DECODE: Nocturnal Scratch

Digital Endpoint Collaboration to accelerate Outcome DEvelopment, (DECODE), in Nocturnal Scratch is a cross-industry collaboration between Ametris and the pharmaceutical companies Janssen, Takeda, and UCB that aims to research and develop a novel, fit-for-purpose digital measure to support patient-focused drug programs for dermatological conditions such as atopic dermatitis (AD) and psoriasis.

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Patient-Focused Digital Measures Reports

Access our dermatology digital measure reports inspired by the FDA’s Patient-Focused Drug Development (PFDD) initiative, leveraging information from Voice of the Patient summaries to highlight how digital health technologies can help measure symptoms that are meaningful to patients.

Experience in Dermatology Trials

11
trials
721
sites
23
countries
1589
participants