NCT05137093

Scratching Validation Study

Independent Validation Study of Nighttime Scratching Quantification With Actigraphy in Adults With Atopic Dermatitis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 27 (actual)
• Sponsor: Philips Clinical & Medical Affairs Global · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: —

Summary

Single center, analyst-blinded, study comparing the scratching events identified via an actigraphy scoring algorithm versus manual scoring of an overnight video recording, undertaken in a sample of 40 adult patients with atopic dermatitis and controls.

Detailed description

The Philips scratching algorithm has been cross-validated against the gold-standard assessment of scratching. The algorithm has been used in many drug development trials, occasionally as a means of generating secondary endpoints, but most often as a means of generating exploratory endpoints. The purpose of the proposed study is therefore to validate the data generated by the scratching study compared to the gold-standard video-assessment of scratching, in an independent sample of adults with atopic dermatitis and age- and sex-matched controls

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DEVICE	Actigraphy Device	Patients will wear actigraphy device which detects scratching events.

Timeline

• Start date: 2021-12-10
• Primary completion: 2023-02-01
• Completion: 2023-02-01
• First posted: 2021-11-30
• Last updated: 2023-03-09

Locations

1 site across 1 country: United States