A Study of the Long-Term Safety of Crisaborole Ointment, 2% in Japanese Pediatric and Adult Participants With Mild to Moderate Atopic Dermatitis

Phase 3TerminatedNCT04498403

Pfizer40 enrolled

Overview

This study is a Phase 3, multicenter, open-label, long-term safety extension study of Studies C3291032 and C3291031 in Japanese pediatric and adult participants with mild to moderate Atopic Dermatitis (AD).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Atopic Dermatitis

Interventions

Crisaborole 2%DRUG

Crisaborole 2% ointment

Eligibility

Sex: ALLMin age: 7 Months

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female participants; * Who were patients with mild to moderate AD aged 2 years old or older and met eligibility criteria for study C3291032 at the time when entering Study C3291032, and completed treatment period in Study C3291032 without safety issues. Or * Who were patients with mild to moderate AD aged 1 months to \<24 months and met eligibility criteria for Study C3291031 at the time when entering Study C3291031, and completed treatment period in Study C3291031 without safety issues Exclusion Criteria: * Has other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.

Locations (11)

Shirao Clinic of Pediatrics and Pediatric Allergy

Hiroshima, Hiroshima, Japan

Chitose dermatology and plastic surgery clinic

Chitose Shi, Hokkaido, Japan

Takagi Dermatological Clinic

Obihiro, Hokkaido, Japan

Outcomes

Primary Outcomes

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

An adverse events (AE) is any untoward medical occurrence in clinical investigation participant administered a product or medical device; event need not necessarily to had a causal relationship with treatment or usage. SAEs: an AE resulting in any of following outcomes/deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are events between first dose of study drug and up to 28 days after last dose of study drug, that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.

Time frame: Baseline up to 28 days after last dose of study drug (maximum up to 12 weeks)

Data from ClinicalTrials.gov

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