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Completed

NCT Number: NCT03770858

Wearable Skin Sensors to Assess Nocturnal Scratch Behavior

Pilot study of flexible and wearable sensor to monitor nocturnal scratching behavior

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

About this study

Present an advanced flexible, and wearable sensor intimately coupled to the skin that can measure the full spectrum of relevant physiological parameters associated with atopic dermatitis including scratch count, scratch duration, scratch intensity, heart rate, heart rate variability and respiratory rate.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants with mild to moderate atopic dermatitis ages 2 years or older. This will be determined by clinical diagnosis of AD according to the Hanifin and Rajka criteria with a baseline Investigators Global Assessment score of mild (2) or moderate (3)
  • Systemic therapy use (e.g. oral corticosteroid, cyclosporine, methotrexate, phototherapy) within 28 days of subject enrollment
  • Topical corticosteroid use or topical calcineurin inhibitor use within 14 days of subject enrollment
  • Willingness and ability to set up an infrared video camera nightly
  • Willing to apply topical crisaborole twice daily to affected atopic dermatitis areas of the body

Exclusion criteria

  • Active skin or systemic infection
  • Inability to operate a smartphone or video camera
  • Active atopic dermatitis on he dorsum of the hand or suprasternal notch

Treatment and study plan

Crisaborole

Drug

Subject to apply topical crisaborole twice daily to the affected atopic dermatitis areas

Scratch sensor

Device

advanced, flexible and wearable skin sensor

Primary outcomes

  1. Percent agreement of scratching between the experimental sensor and the infrared camera

    Time frame: 3 weeks

Secondary outcomes

  1. Improvement of sleep parameters (time asleep) measured by the experimental sensor during treatment

    Time frame: 3 weeks

    Baseline compared to treatment time points will be compared in units of time (minutes/hours)

  2. Improvement of sleep parameters (time until onset of sleep) measured by the experimental sensor

    Time frame: 3 weeks

    Baseline compared to treatment time points will be compared in units of time (minutes/hours)

  3. Improvement of sleep parameters (heart rate) measured by the experimental sensor

    Time frame: 3 weeks

    Baseline compared to treatment time points will be compared in units of beats/min

  4. Improvement of sleep parameters (respiratory rate) measured by the experimental sensor

    Time frame: 3 weeks

    Baseline compared to treatment time points will be compared in units of breaths/min.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Pfizer

Registry information

Official study title

A Single Arm, Prospective Clinical Study Using Novel Wearable Sensors to Assess the Improvement of Nocturnal Scratch Behavior and Sleep Quality in Children With Mild-to-moderate Atopic Dermatitis Treated With Topical Crisaborole

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Dec 10, 2018
Registry last updated
Oct 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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