drugset / Trial / NCT05200403

Improvement In Scratch Behavior And Sleep In Patients With Atopic Dermatitis

NCT05200403

Phase 4 Terminated 72 enrolled Boston University Pfizer · collab
RandomizedParallel-groupSingle-blindTreatment

Summary

This single blind study is to primarily evaluate wearable devices and Observer Reported Itch Assessment in children to assess reduction of itch and night-time scratch in response to Crisaborole treatment vs. vehicle treatment (active control comparator without crisaborole) in children with atopic dermatitis (AD). Participants, age 3 months to 11 years with symptomatic mild to moderate AD, along with their primary caregivers will be recruited. The goal of this study is to more fully evaluate the rapid onset of night-time itch and scratch relief, as well as improvements in sleep following treatment with Crisaborole in comparison to vehicle treatment in children with AD. the study will also assess the quality of life (QoL) and sleep within the associated caregivers.

Timeline

Start
2022-07-26
Primary completion
2024-02-15
Completion
2024-02-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Crisaborole Small molecule 2 % Topical

Indications