A Study of the Long-Term Safety of Crisaborole Ointment, 2% in Japanese Pediatric and Adult Participants 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

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-14

Study Completion Date

2020-12-18

Brief Summary

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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).

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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

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Crisaborole 2%

Crisaborole 2% ointment applied twice daily (BID)

Group Type EXPERIMENTAL

Crisaborole 2%

Intervention Type DRUG

Crisaborole 2% ointment

Interventions

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Crisaborole 2%

Crisaborole 2% ointment

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

7 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No