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Trials / Completed

CompletedNCT03961529

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

A Multicenter, Open-label, Uncontrolled, Long-term Trialto Demonstrate the Safety and Efficacy of 1% OPA-15406 Ointment in Adult Patients With Atopic Dermatitis and of 0.3% and 1% OPA-15406 Ointments in Pediatric Patients With Atopic Dermatitis (Phase 3 Trial)

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
366 (actual)
Sponsor
Otsuka Pharmaceutical Co., Ltd. · Industry
Sex
All
Age
2 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DRUG0.3% OPA-15406 ointmentTwice daily
DRUG1% OPA-15406 ointmentTwice daily

Timeline

Start date
2019-05-14
Primary completion
2020-11-11
Completion
2020-11-11
First posted
2019-05-23
Last updated
2021-11-19
Results posted
2021-11-19

Locations

1 site across 1 country: Japan

Source: ClinicalTrials.gov record NCT03961529. Inclusion in this directory is not an endorsement.

Long-term Trial of OPA-15406 Ointment in Adult and Pediatric Patients With Atopic Dermatitis (NCT03961529) · Clinical Trials Directory