Scratch Behavior Under Standard of Care

Completed

Conditions studied: Atopic Dermatitis

In brief

Wrist-worn accelerometers and associated data analysis platforms will provide quantitative and qualitative knowledge regarding the action of scratching and sleep quantity in a symptomatic Atopic Dermatitis (AD) population. The overall research aim is to evaluate the sensitivity of digital devices to capture drug-induced (standard of care treatments; SOC) quantitative changes in nighttime scratch and sleep quantity in AD subjects. In the current study, the investigators aim to evaluate the ability of wrist-worn accelerometers to detect significant and clinically meaningful changes in scratch behavior and sleep quantity in patients with symptomatic AD aged 2 to 75 years, receiving topical SOC treatment for AD. To evaluate this experimental paradigm, using wearable accelerometers, traditional patient-reported outcome measures/observer-reported outcome (ObsRO) (PRO/ObsRO), thermal videography and physician assessments of AD will be assessed in a well-controlled observational methodology study that has both an in-patient and out-patient portions within the study.

Key facts

Study ID

NCT03898427

Run by

Boston University

People needed

100

Starts

2019-04-04

Expected to finish

2020-12-15

Last updated by the study team

2021-03-03

Who can join

Age: 2 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects aged between ≥2 years of age and <75 years of age at Day 1.
• Written informed consent from subject/parent(s)/guardian(s) and assent from the subject, where assent is applicable (for those subjects under 18 years of age).
• Subject and parent(s)/guardian(s) are willing and able to comply with study instructions, study visits, and procedures.
• Native English speakers or demonstrated fluency in English (both subject and parent(s)/guardian(s) in the case of minors).
• Have a clinical diagnosis of AD according to the criteria of Hanifin and Rajka.

You may not qualify if…

• Has any clinically significant medical disorder, condition, disease (including active or potentially recurrent non AD dermatological conditions and known genetic dermatological conditions that overlap with AD, such as Netherton syndrome) or clinically significant finding at screening that precludes subject's participation in study activities.
• Allergy to polyurethane resin (strap/wristband component), skin nickel allergy, silicone, and/or adhesives.
• Has documented non-AD related insomnia, sleep apnea or other sleep-related disorders (e.g., narcolepsy, restless legs syndrome, circadian rhythm disorder).
• Has unstable AD (Total BSA>40%) (including a significant active systemic or localized infection).

Where it is running

• Evans Biomedical Research Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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