Study of OPA-15406 Ointment in Patients With Atopic Dermatitis

Otsuka

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: OPA-15406; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02914548

JapicCTI-163372 (Other Identifier)

271-15-001

Details and patient eligibility

About

The purpose of this study is to assess the efficacy and safety of OPA-15406 ointment in patients with atopic dermatitis.

Enrollment: 200 patients

Sex: All

Ages: 15 to 70 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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200 participants in 3 patient groups, including a placebo group

0.3% OPA-15406

Experimental group

Description:

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

Treatment:

Drug: OPA-15406

1% OPA-15406

Experimental group

Description:

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

Treatment:

Drug: OPA-15406

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo