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A Multicenter, Randomized, Double-blind, Vehicle-controlled, Parallel-group Trial to Assess the Safety and Efficacy of 0.3% and 1% OPA-15406 Ointments When Administered for 4 Weeks in Pediatric Patients With Atopic Dermatitis

A Multicenter, Randomized, Double-blind, Vehicle-controlled, Parallel-group Trial to Assess the Safety and Efficacy of 0.3% and 1% OPA-15406 Ointments When Administered for 4 Weeks in Pediatric Patients With Atopic Dermatitis

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080223429
Enrollment
60
Registered
2017-01-06
Start date
2017-01-06
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Interventions

investigational material(s) Generic name etc : OPA-15406 Ointment (0.3%, 1% ) INN of investigational material : Therapeutic category code : 269 Other agents for epidermis Dosage and Administration fo

Sponsors

Otsuka Pharmaceutical Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Diagnosis of atopic dermatitis based on the criteria of Hanifin and Rajka

Exclusion criteria

Exclusion criteria: - Subjects who have an atopic dermatitis or contact dermatitis flare-up defined as a sudden intensification of atopic dermatitis. - Subjects who have an active viral skin infection. - Subjects with a current or history of malignancy.

Design outcomes

Primary

MeasureTime frame
The number and percentage of subjects experiencing AEs—

Secondary

MeasureTime frame
IGA, EASI and plasma concentration of OPA-15406—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026