A Long-term Trial of OPA-15406 in Infants With Atopic Dermatitis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-23

Study Completion Date

2023-11-29

Brief Summary

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To investigate the efficacy of 0.3% OPA-15406 ointment when administered twice daily for 4 weeks in infants younger than 2 years of age with Atopic Dermatitis

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Detailed Description

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Conditions

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Atopic Dermatitis (AD)

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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OPA-15406

Group Type EXPERIMENTAL

OPA-15406

Intervention Type DRUG

0.3% or 1% ointment, topical, twice daily, for 52 weeks

Interventions

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OPA-15406

0.3% or 1% ointment, topical, twice daily, for 52 weeks

Intervention Type DRUG

Other Intervention Names

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difamilast

Eligibility Criteria

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Inclusion Criteria

* Subjects who are diagnosed with AD in accordance with the criteria of the Japanese Dermatological Association
* Subjects whose AD affects 5% to 40% of BSA (excluding scalp) at the screening and baseline examinations
* Subjects who have an IGA score of 2 or 3 at the screening and baseline examinations