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Improvement In Scratch Behavior And Sleep In Patients With Atopic Dermatitis

NCT05200403 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2025-03-14

Study results available
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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.

Conditions

Interventions

DRUG

Crisaborole 2%

The adult caregiver will apply a thin layer of Crisaborole 2% topically on their child participant twice a day for 2 weeks.

DRUG

Vehicle treatment

The adult caregiver will apply a thin layer of the vehicle treatment topically on their child participant twice a day for 2 weeks. The vehicle treatment is made of excipients of crisaborole ointment (non-medicated ointment).

DEVICE

Accelerometry device for children

Children participants will wear two wrist worn (or wrist worn AND ankle worn for 3 months up to \<2 years) accelerometry devices. Devices will be optional for child participants who have active AD on location of device placement, with a minimum of at least one wrist device needed for enrollment.

DEVICE

Accelerometry device for adult caregivers

Adult caregiver participants will wear two accelerometry devices (one on each wrist) and complete daily assessments related to scratching, sleeping habits, pain, AD severity, quality of life, and device comfort questionnaires.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Boston University

    lead OTHER

Principal Investigators

  • Kevin C Thomas, PhD · BU School of Medicine, Anatomy and Neurobiology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-26
Primary Completion
2024-02-15
Completion
2024-02-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05200403 on ClinicalTrials.gov