NCT03911401

Brief Summary

To demonstrate the superiority of the investigational medicinal product (IMP; 0.3% OPA-15406 ointment, 1% OPA-15406 ointment, or vehicle) to the vehicle when administered twice daily for 4 weeks using success rate in Investigator's Global Assessment (IGA) at Week 4 as the primary endpoint in pediatric patients with Atopic Dermatitis (AD).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
251

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2019

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 11, 2019

Completed
26 days until next milestone

Study Start

First participant enrolled

May 7, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 25, 2021

Completed
Last Updated

January 25, 2021

Status Verified

January 1, 2021

Enrollment Period

7 months

First QC Date

April 9, 2019

Results QC Date

January 5, 2021

Last Update Submit

January 5, 2021

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

  • Responder Rate of Investigator's Global Assesment (IGA) of Disease Severity

    The investigator or subinvestigator assessed the skin symptoms using IGA. The investigator or subinvestigator scored the severity (0 = clear, 1 = almost clear, 2 =mild, 3 = moderate, 4 = severe/very severe) of the overall symptoms of the treatment area (erythema, infiltration, papules, effusion and scab formation) from baseline to Week 4. Incidence of success in IGA is defined as the rate of subjects whose IGA score is 0 (clear) or 1 (almost clear) and has improved by at least 2 grades (responders) from baseline.

    At Week 4

Secondary Outcomes (2)

  • Change From Baseline in Eczema Area and Severity Index (EASI) Score

    Baseline, Week 4

  • Change From Baseline in Verbal Rating Scale (VRS) for Pruritus Score

    Baseline, Week 4

Study Arms (3)

0.3% OPA-15406

EXPERIMENTAL

Twice daily

Drug: 0.3% OPA-15406

1% OPA-15406

EXPERIMENTAL

Twice daily

Drug: 1% OPA-15406

Placebo

PLACEBO COMPARATOR

Twice daily

Drug: Placebos

Interventions

0.3% OPA-15406DRUG

Twice daily

0.3% OPA-15406
1% OPA-15406DRUG

Twice daily

1% OPA-15406
PlacebosDRUG

Twice daily

Placebo

Eligibility Criteria

Age2 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosis of AD based on the Japanese Dermatological Association's criteria
  • Atopic dermatitis affecting more than or equal to 5%, to less than or equal to 40% of body surface area (BSA, excluding scalp) at the screening and baseline examinations
  • IGA score of 2 or 3 at the screening and baseline examinations

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kato Dermatology Clinic

Sapporo, Japan

Location

Related Publications (1)

  • Saeki H, Baba N, Ito K, Yokota D, Tsubouchi H. Difamilast, a selective phosphodiesterase 4 inhibitor, ointment in paediatric patients with atopic dermatitis: a phase III randomized double-blind, vehicle-controlled trial. Br J Dermatol. 2022 Jan;186(1):40-49. doi: 10.1111/bjd.20655. Epub 2021 Nov 1.

    PMID: 34289086DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

difamilast

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Results Point of Contact

Title
Director of Clinical Trials
Organization
Otsuka Pharmaceutical Co., LTD.
CL_OPCJ_RDA_Team@otsuka.jp
+81-3-6361-7366

Study Officials

  • Osamu Sato

    Otsuka Pharmaceutical Co., Ltd.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2019

First Posted

April 11, 2019

Study Start

May 7, 2019

Primary Completion

December 13, 2019

Study Completion

December 13, 2019

Last Updated

January 25, 2021

Results First Posted

January 25, 2021

Record last verified: 2021-01

Locations

JP(1)