Trial intelligence / Profile preview

Crisaborole for steroid reduction in pediatric eczema

NCT03832010Phase 4

Key facts

Status: Completed
Start: Dec 2019
Primary completion: Feb 2024
Countries: 1
Sponsor: Johns Hopkins University

Drugs: AN2728 ointment vehicle
Conditions: atopic dermatitis (AD)

Overview

Phase 4, randomised, double-blind trial of AN2728 ointment vehicle in atopic dermatitis (AD) (3 arms), sponsored by Johns Hopkins University. Primary endpoints: Steroid Usage Quantity at Day 90 and Steroid Usage Frequency at Day 90. Started Dec 2019; status: completed.

Design

3 arms

Study design: RandomizedDouble-blind

Crisaborole
Crisaborole + TCS + Emollient
Vehicle
Vehicle + TCS + Emollient
Control
Emollient + TCS + Emollient

Who it enrols

Children aged 2-17 with mild to moderate atopic dermatitis (IGA 2-3). Excludes severe AD (IGA 4) and known allergies to study products.

Endpoints

Primary

Steroid Usage QuantityDay 90
Steroid Usage FrequencyDay 90

Secondary

SCORing Atopic DermatitisDay 90
Children's Dermatology Life Quality IndexDay 90
Dermatitis Family Impact QuestionnaireDay 90
Pruritus ScoreDay 90

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