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Long-term Trial of OPA-15406 Ointment in Adult and Pediatric Patients With Atopic Dermatitis

NCT ID: NCT03961529

Last Updated: 2021-11-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

366 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-14

Study Completion Date

2020-11-11

Brief Summary

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To demonstrate the safety of 1% OPA-15406 ointment in adult patients with AD and of 0.3% and 1% OPA-15406 ointments in pediatric patients with AD administered twice daily for 52 weeks.

Detailed Description

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Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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0.3% OPA-15406 ointment

Twice daily

Group Type EXPERIMENTAL

0.3% OPA-15406 ointment

Intervention Type DRUG

Twice daily

1% OPA-15406 ointment

Twice daily

Group Type EXPERIMENTAL

1% OPA-15406 ointment

Intervention Type DRUG

Twice daily

Interventions

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0.3% OPA-15406 ointment

Twice daily

Intervention Type DRUG

1% OPA-15406 ointment

Twice daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age: At least 2 years (at time of obtaining informed consent)
* Diagnosis of AD based on the Japanese Dermatological Association's criteria
* Atopic dermatitis affecting ≥5% of body surface area (BSA, excluding scalp) at the screening and baseline examinations

Exclusion Criteria

\- Subjects who have an AD or contact dermatitis flare-up defined as a rapid intensification of AD, within 28 days prior to the baseline examination
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Osamu Sato

Role: STUDY_DIRECTOR

Otsuka Pharmaceutical Co., Ltd.

Locations

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Shirao clinic of pediatrics and pediatric allergy

Hiroshima, , Japan

Site Status

Countries

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Japan

References

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Saeki H, Imamura T, Yokota D, Tsubouchi H. Difamilast Ointment in Japanese Adult and Pediatric Patients with Atopic Dermatitis: A Phase III, Long-Term, Open-Label Study. Dermatol Ther (Heidelb). 2022 Jul;12(7):1589-1601. doi: 10.1007/s13555-022-00751-9. Epub 2022 Jun 18.

Reference Type DERIVED
PMID: 35716332 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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271-102-00006

Identifier Type: -

Identifier Source: org_study_id