Phase 2 Study of OPA-15406 Ointment in Pediatric Patients With Atopic Dermatitis

Otsuka

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: Placebos; Drug: OPA-15406

Study type: Interventional

Funder types: Industry

Identifiers

NCT03018691

271-102-00002

JapicCTI-173484 (Other Identifier)

Details and patient eligibility

About

To evaluate the safety, efficacy (dose response) and pharmacokinetics of 0.3% and 1% OPA-15406 when applied twice daily for 4 weeks in pediatric patients with atopic dermatitis.

Enrollment: 73 patients

Sex: All

Ages: 2 to 14 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of atopic dermatitis based on the criteria of Hanifin and Rajka

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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73 participants in 3 patient groups, including a placebo group

0.3% OPA-15406 Ointments

Experimental group

Description:

Subjects were treated with assigned 0.3% OPA-15406 ointment twice daily.

Treatment:

Drug: OPA-15406

1% OPA-15406 Ointments

Experimental group

Description:

Subjects were treated with assigned 1% OPA-15406 ointment twice daily.

Treatment:

Drug: OPA-15406

Placebo Ointments

Placebo Comparator group

Description:

Subjects were treated with assigned 0% OPA-15406 ointment twice daily.

Treatment:

Drug: Placebos