Study to Assess Efficacy and Safety of Two Regimens of Crisaborole Ointment 2% in Japanese Participants Aged ≥2 Years With Mild to Moderate Atopic Dermatitis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-15

Study Completion Date

2019-12-16

Brief Summary

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This is a Phase 2b, multi-center, randomized, double-blind, vehicle-controlled, intraparticipant study to evaluate efficacy and safety of two regimens of crisaborole ointment 2% in Japanese pediatric and adult participants (cohort 1: 12 years and older, cohort 2: 2 to under 12 years old) with mild to moderate Atopic Dermatitis (AD).

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Detailed Description

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Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Crisaborole ointment 2% once daily (QD) vs vehicle QD

intra-participant comparison, treatment will be randomly assigned to target lesion 1 and lesion 2.

Group Type EXPERIMENTAL

Crisaborole ointment 2%

Intervention Type DRUG

QD regimen

Vehicle

Intervention Type DRUG

QD regimen

Crisaborole ointment 2% twice daily (BID) vs vehicle BID

Intra-participant comparison, treatment will be randomly assigned to target lesion 1 and lesion 2.

Group Type EXPERIMENTAL

Crisaborole ointment 2%

Intervention Type DRUG

BID regimen

Vehicle

Intervention Type DRUG

BID regimen

Interventions

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Crisaborole ointment 2%

BID regimen

Intervention Type DRUG

Vehicle

BID regimen

Intervention Type DRUG

Crisaborole ointment 2%

QD regimen

Intervention Type DRUG

Vehicle

QD regimen

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female participants ages; Cohort 1: 12 years and older at the time of consent. Cohort 2: 2 years to under 12 years old at the time of consent.
* Has confrimed clinical diagnosis of active AD according to Hanifin and Rajka criteria and has at least 6 months history prior to screening and has been clinically stable for more than 1 month
* Has at least 1% and no more than 30% BSA at baseline/Day1, excluding scalp, genitals and groin area
* Has a Investigator's static global assessment (ISGA) score of Mild (2) or Moderate (3) on Day 1.

Exclusion Criteria

* Has other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
* Participants had previous treatment with any topical or systemic PDE-4 inhibitor.

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No